Biosimilars' Growth in Pharmerging Markets: An Analysis of the Regulatory Environment

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This article analyzes the regulatory environment of biosimilars' growth in pharmerging markets. It discusses the key factors for biosimilars' introduction onto the market, biosimilars' competition with the originator, and the role of regulatory authorities for biosimilars. It also presents recommendations for a better regulation of biosimilars in pharmerging markets.

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Running Head: Biosimilars' growth in pharmerging markets: An analysis of the regulatory
environment
Ryma Batel
University of the Western Cape in collaboration with Hibernia College

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Table of Contents
CHAPTER 1 - INTRODUCTION 1
Introduction 1
Background 2
Problem Statement 3
Research Aims and Objectives 4
Research Questions 4
Research Hypotheses 5
Methodology to Follow Aims and Objectives 5
SWOT Analysis 6
CHAPTER 2: LITERATURE REVIEW 8
Introduction 8
Market position of Biosimilars 9
Contrasting Emerging Markets and Old Players in Biosimilars 10
Growth of Biosimilars in Emerging Markets 11
Changing Forces Shape Growth of Biosimilars 13
Opportunities and Challenges for Biosimilars in Emerging Markets 14
CHAPTER 3: ANALYSIS OF FINDINGS AND DISCUSSION 17
External Research: Online Survey 17
Quantitative Research: SWOT Analysis 20
Strengths 20
Weaknesses 22
Opportunities 25
Threats 27
Hypotheses 29
CHAPTER 4 - CONCLUSION 31
Recommendations 32
REFERENCES 34
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CHAPTER 1 - INTRODUCTION

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Introduction
Globalisation has led to multinational biotechnological companies and push products to acquire
more markets in the world. Nowadays, a biosimilar is expected by the European Medicines
Agency (EMA) to contribute to the sustainability of the healthcare system in Europe and to
improve the availability of biological medicines to the patient (Tabernero, et al. 2017). This
statement could be true if the penetration of the biosimilar of the accessible market is relevant.
The flagrant difference in pricing between the product and originator is the most important factor
which will drive the biosimilar market performance and will bring the sustainability in a
healthcare system. In addition, a more favourable monitoring system could be an excellent
outcome (Aitken, 2016).
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On the other hand, there have been many contributing factors that have led to the increasing
demand for a biosimilar market. For instance, factors such as the growing demand of biosimilars
because of its cost effectiveness, increased pressure on the decreased expenditures of health care,
increased occurrence of various new diseases, increased numbers of biologics dropping their
exclusivity of market, constructive results in continual clinical trials, in addition to the increased
demand in different applications of therapeutics (Bruche, 2012). On the other hand, it has also
been estimated that nearly thirty-nine biologics that represented almost 30% of the overall
market would more likely lose its marketing exclusivity between the year 2015 and 2019
representing $41 billion of US sales (Wiatr, 2011). This viewpoint has resulted in achieving
increased interest by the majority of the key companies operating in the pharmaceutical and
biotech industry as they had started planning to make ventures into the biosimilar segment so
that they could effectively gain the share of multi-billion worth in the growing market of
biologics. However, other factors that have increased the demand for the drug in the biosimilar
market involve increasing disease occurrences that are taking place around the world, in addition
to the increased access to facilities of health care for all countries (Bruche, 2012).
Background
As stated by Senior (2013), the availability of biosimilars will certainly not enhance
competition as generics onto the market because the global players will not facilitate their
introduction, they have learnt from the generic experience, they will probably develop their own
follow-on originator and invest in emerging market. Consequently, biosimilars will probably be
the second-largest source of growth but questions still remain over regulatory requirements.
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Understanding this potential is neither simple nor definite (Huzair and Kale, 2015). The absence
of consistency crosswise over EU countries that have had entry to biosimilar drugs for more or
less ten years proposes the basic components of accomplishing the maximum capacity from
biosimilar drugs are not surely known at a policy level nor executed successfully at a practical
level.
Multinational biosimilar improvement programs incorporate emerging countries to adjust
effective registration of patient, different levels of regulatory requirements and potential market
opportunities. Varieties in registration efficiencies and regulatory requirements can bolster
biosimilar market registration sooner in some emerging nations, permitting developers to seek
procedures to acquire registration first in developing markets, then present biosimilar products in
Europe and the U.S. On the other hand, Huzair and Kale (2015) stated that the emerging
pharmaceutical markets of Asia, Latin America and Eastern Europe offer especially attractive
locations for biosimilars research and commercialisation. Not only these are the emerging
nations characterised by the growing middle class and increasing healthcare expenditures, but
they are also typically generic driven pharmaceutical markets; this provides a positive medical
and commercial environment for biosimilars (Miletich, Eich, Grampp and Mounho, 2011).
Problem Statement
II- Statement of the problem:
Will the growth of biosimilars onto the pharmerging market have similar effect
as generics?
There are many questions regarding the cost and manufacturing of biosimlars and the
interchangeability question which could pose serious public health problems. However, the main

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problem is the regulatory system in emerging countries which is new and not as stringent as in
US or Europe.
There has been much debate in the industry concerning the future of biosimilars and how
analogous they are to the generic market.
However, the biosimilar competition seems to be different from the generic small
molecule competition onto the market (Liang, 2012; Zhang, 2012). It is noticeable that biosimilar
industries are not a formidable competitor as generics in a commercial area, the costs are hugely
different, and barriers which biosimilars are facing are so large and cannot be easily prevailed.
Therefore, a comparison between generics and biosimilars is essential and valuable to emphasise
their way of commercialization and sustainability the in healthcare system. According to Zhang
(2012), the future of biosimilars compared to the past of generics is an important point to start
the analysis of regulatory strategies in emerging markets.
Research Aims and Objectives
In this project I propose to review the literature about the biosimilars' basics facts in order to
understand why the product is not present in the market as generics. In this review I will achieve
two goals the first one is to explain the criteria for a suitable market application of biosimilars
and the second one is to determine how to meet this criteria for a successful penetration and
evolution onto the market but overall I will present analysis of the regulatory environment .
Specific aims are also developed for the study which is shown below:
1: Use literature review to define the key factors that occur on the marketing of biosimilars and
relate the hypothesis to previous knowledge.
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2: Online survey will give some statistical data which will consolidate the hypothesis on
marketing the biosimilars in emerging countries
3: SWOT analysis strengthens the knowledge of the market and the environment in depth from a
strategic management's perspective.
Research Questions
After understanding the research problem and having a basic understanding of the
research topic, the following research questions were developed for this study:
Research Questions:
Q1: What are the key factors for biosimilars' introduction onto the market?
Q2: Will the competition of biosimilars with their originators resemble one of generics?
Q3: Will the biosimilars growth onto the emerging market is similar to the one of generics?
Q4: Will the operational factors in emerging countries be the main burden for sponsors?
Q5:What is the role of the regulatory authorities for Biosimilars ?
Q6:How to lower the risk of issuing a regulatory decision in the emerging countries?
Q7:How to meet the criteria for successful and evolution of biosimilars onto the pharmerging
market?
Q8:What are the pharmerging market strategies for a better regulation of biosimilars?
Q9:How to increase patients access to biosimilars ?
Q10:How assess Regulatory framework of emerging markets?
Research Hypotheses
The following hypotheses were developed for this study:
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Hypothesis:
H1: Pricing and biosimilarity are the main key factors of the biosimilars' introduction onto the
market.
H2: The Biosimilars’ competition with the originator will be different from the one of the
generics.
H3: The penetration of emerging market will be a big challenge for stakeholders.
H4: The operational factors such as clinical trials and regulatory requirement will be problematic
for sponsors.
H5: regulatory authorities develop a specific, appropriate, regulatory framework for approving
biosimilars that is distinct from the regulatory procedures previously applied to copy-version
products
H6: Rise the knowledge of Regulatory science by investing in Regulatory training programs
H7 :National databases or registries to record details of biological switching, particularly adverse
event profiles, so as to obtain safety data post-switching
H8: policy implementation to promote healthier competition in medicine pricing and to make
medicines more affordable
H9: communication, trust and education in order to increase patient access to biosimilars
H10 :Carefully assess regulatory frameworks

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CHAPTER 2: LITERATURE REVIEW
Review of Literature:
In this review I have come across the key articles which are essential. This is because not all the
literature which will be used has been reviewed. My project will be devised into four parts,
eventually the first one will be the introduction, some definitions must be given on biosimilars
and generics to understand the difference between them biologically.
Michał Nowicki in his review "basic facts of biosimilars”, 2007, he reported that the expiry of
patent protection for many original biotechnological medicines has led to the development of
what are called biosimilars or follow-on biologics. The biosimilars attempt to copy the original
technology leading to the production of innovative biotechnological medicines to obtain a
product which is similar to the original one. As a result, the reference copy could be
manufactured and marketed by small biopharmaceutical companies. Therefore, it will be
witnessed that new competitors are challenging the reference medicines. From his article it can
be understood that he supports the point that biosimilars will have a positive impact in future on
healthcare landscape.
The second one will be the Qualitative discussion and will be composed of Chapter I, Chapter II
and Chapter III respectively.
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In Chapter I: Commercial Issues being the major concern, Ira S et al ,2010, discussed the
manufacturing cost issue of biosimilars which is the main concern of stakeholders in terms of
pricing comparing to generics. For instance, if the differences detected between biosimilar and
the reference product are large and exceed the variability limits of the reference product,
similarity may not be justified and may affect the safety and efficacy of the biosimilar product.
According to Blackstone & Joseph, 2013, in the same topic of economics of biosimilars, they
stated that for the market of biosimilars to develop different from the generic market, various
factors including safety, pricing, manufacturing, entry barriers physician acceptance and
marketing will take part. From their article it is also noted that the barriers for biosimilars to
enter into the market are much more difficult to overcome than it is typically seen with small-
molecule generic drugs. It is therefore, recommended that the biosimilar manufacturer is
supposed to be able to meet the quality required with all the challenges that come with
manufacturing and commercialization of biosimilars for effectivity.
Chapter II: Commercial opportunities and possible success, Rotenstein et al.2012 has illustrated
the opportunities of biosimilars by evoking the example of insulin challenges market. It has been
reported that "... Biosimilar insulins have the potential to reduce diabetes treatment costs,
increase the accessibility of insulin treatment, and expand the number of insulin brands available
for those with diabetes..." adding the same on the point of cost effectiveness of the biosimilars as
compared to the high-priced branded biologics, Blackstone & Fuhr Jr, 2012, supported the same
point but on the basis of efficacy and patient safety of biosimilars. They confirmed that the
market competition is at stake but still the biosimilars are expected to penetrate into the market
due to their efficacy and patient safety.
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The article of Rotenstein et al.2012 also added some information and wrote about the major
challenges of commercializing biosimilars. Among the concerns pointed out, one of them is the
necessity of education. In this the authors suggested companies to sponsor the education for
clinicians so that it can be at a significant cost as is done for branded products in order to
overcome the uncertainty concern. This is because most of the stakeholders including physicians,
patients and payers may be unfamiliar with the information concerning biosimilars. In addition, a
lack of agreement regarding the nomenclature for biosimilars could cause doubt about efficacy
of the products and could thereby influence pharmacy substitution. Consequently, every single
one of these key concerns are related to the commercial success of the product.
In Chapter III of the context: Regulatory issue will be discussed. This one will take into
consideration the quality, safety and efficacy of all new products (biosimilars) to penetrate the
market that is competitive. The contribution of regulations has an important role on the
sustainability of the biosimilar medicine market. This may be done by having a good impact as it
promotes the competition at the same time increasing the trust of stakeholders. On the other
hand, it may have a negative impact by declining the sustainability of the biosimilars and lead to
an unfair return in investment (RIO).

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I, therefore, came across two articles that can be reviewed when talking about the regulations of
the biosimilars in the competitive market. The first one by Andrzej Wiecek et al.2006, which has
discussed the European guideline EMEA. In this the authors of the article reported that the
EMEA has forged ahead in providing guidance for national regulatory bodies in Europe.
However, this article was published in 2006, and as a result, the progress of regulatory bodies
has been changing. The second article was by Bockmeyer et al.2012. In this, the authors have
evoked the comparability exercise issue in regulation which is required to ensure the efficacy and
safety of the product. Conversely, state laws barring substitution may have an impact on "free
market competition". Finally, the basis for the regulation on biosimilars is to recess the high
price of biologic therapies by reducing the cost of their clinical development.
The third part will be about the quantitative discussion to support the qualitative, the more the
numbers are added to the words, the more the work could be valuable. According to Alaaric
Deerment,2011 in his report, anticipating regulation, biosimilars move through pipeline Generic
Report, has presented: the key biosimilar manufacturer in the world; treatment rejection out-of-
pocket cost in 2010 by rejecting each product by patient, which impact could be have on
manufacturer of biogenerics; Top branded and generics prescription by disease state in 2010.
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Charts from IMS health, 2011 could be added to support the analysis of the biosimilar's market
penetration as it is reported in the article published by IMS health, shaping the biosimilars
opportunity,” It was expected that by 2015, sales of biosimilars should have raised to US$1.9-2.6
billion from US$378 million for the year to the first half of 2011. Potentially, this market could
have been the single fastest-growing biologics sector in the next five years – albeit from a small
base – spurred by the convergence of major dynamics that will see new biosimilars enter the US
market by 2014, bring additional molecules to Europe through 2015, and open up oncology and
autoimmune disease areas to biosimilars for the first time ever." In the article of Silver S.
Industry surveys: biotechnology. Standard & Poor's. February 2013, it has been reported that
there was an estimation of 32 biologics, with a combined $51 billion of sales in 2009 that would
have lost their patent by the year 2015.
In the article of Erwin et al. 2013, the authors reported that "... Despite all the difficulties, it is
expected that the market will develop, given the potential profits with patent expiration. ...The
12-year market exclusivity is probably adequate. The biosimilar market will become more
prominent, but this will take considerable time and effort."
However, all of These statements from the different articles could not be true, as we are in 2016
other reliable articles could have been added along the way up to this year to validate it or
dispute it.
The last part will be ultimately the conclusion, in this part my point of view will be expressed
and articles criticized.
Literature Review Results:
Name / year /Study Relevant points Limitations of the study Supportive to the
project
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Aalaric Deerment/2011/ anticipating regulation, biosimilars move through pipeline Tables
and statistics on costs of industries /diseases The study has been done in 2010. +
Anjen Selz/ 2010/ A SWOT analysis of the biosimilar market, FINOX AG.
Defining the strength :lower cost structure, weakness: lack of credibility in regulation and
industry, opportunities: continuing growth on saturated market and threats: conflict of interest
regulatory/industry interest A comparison with generics could be more supportive to analyse
the market of biosimilars . ++
Asterios et al /2013/ Current Status and Future Challenges Bio Drugs. Biosimilars
regulation issues in EU, Table of approved biosimilars in EU
Comparability Exercise.
Many questions have been asked and future challenges in regulations has been discussed the
study focus only on current status of regulation in EU albeit it presented also the FDA recent
concept.
No comparison with generics +++
Andrzej et al., 2006, European Guidelines for biosimilars EMEA issues Articles written in
2006 and focused only on European guideline +
Brian & Feagan, 2014, The challenge of indication extrapolation for infliximab biosimilars.
Similarity in quality between biosimilar and reference. Table illustrated Regulatory
considerations for indication extrapolation for biosimilars. The study focusses on monoclonal
antibodies (mAbs) comparative Quality Safety/ reference +
Carsten, 2012, Developing quality biosimilars, Applied clinical trials Journal.
Quality CMC Comparability exercise and free market competition concern.

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Biosimilars in emerging markets. The peer reviewed has not compared the introduction of
generics in emerging market in the past to a future penetration of biosimilars, this point is very
important +++
Erwin, 2013, The economics of Biosimilars Patent expiration. No other opportunities have
been presented albeit a strong agreement of biosimilars evolution into the future market +
Ira S. Krull, 2010/biosimilars introduction, concerns and opportunities Cost of manufacturing
impact the cost of biotechnological therapies is at present a relatively small portion of
the total healthcare expense in the developed society, this is expected to grow to about 30%
in the next 10 years biosimilars are firstly expected to be priced
at a 20 to 25% discount in comparison to the original products but this discount is
significantly smaller than what is seen in the small molecule generics which is up to 90% ++
Lisa S. Rotenstein
/2012/Opportunities and Challenges for Biosimilars: What’s on the Horizon in the Global Insulin
Market?
The interchangeability issue which could pose serious public health problems, with
important commercial consequences. Because doctors will likely not feel confident switching
patients from a non-interchangeable biosimilar to a reference
product or another non-interchangeable biosimilar policy makers are struggling with an
inherent conflict between desire to provide improved access to better medicines and the need
to curb the growth of healthcare expenditures. ++
Marı´a-Isabel Farfan-Portet, 2014, Are biosimilars the next tool to guarantee cost-containment
for pharmaceutical expenditures?
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Very relevant Discussion points on the future of biosimilars and a comparison of
biosimilars and generics tables and diagrams that are relevant for the study to support the
arguments laid out has been given in the study. Some of the conclusion has been drawn on
expectations. ++++
Michał Nowicki/ 2007/Basic Facts about Biosimilars the originator is a complex, and
difficult to structurally define;
and require specific conditions to ensure stability in contrast to small-molecule drugs. Thus,
minute differences in chemical modifications and higher-order physical structure can
significantly alter a final protein product’s safety and efficacy. Therefore, this tiny difference
may lead to a huge amount of uncertainty. An appropriate investment in commercial and
marketing strategies may make prescribers aware of the possibilities and qualities of these less
expensive alternatives +++
Silver S. /2013/ Industry surveys: biotechnology Estimation of biologics loss of patent by 2015.
The article has been written in 2013, it could not be reliable in current time. ++
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Chapter III Methodology:
The methodology used in this study was based on a mixed methods approach. First of all,
the qualitative research approach was a major part of the project. The collection of data was
structured, retrospectively achieved by a literature review based on conceptualised grounded
theory. The resources for the literature review were accessed by articles and books obtained from
Hibernia College library.
To consolidate the analysis and test the hypothesis, the quantitative research can be used.
The conduction of the discussion is drawn on presenting the key issues of the biosimilars'
introduction onto the market. In this field, the regulatory issue is the main barrier to biosimilars
introduction and evolution onto the market. Meanwhile, policy makers are struggling with an
inherent conflict between a desire to provide improved access to better medicines and the need to
curb the growth of healthcare expenditure. The first question which could be asked is how this
issue is impacting on biosimilar future policies and regulations?
In addition, biosimilar competition seems to be different from generic small molecule
competition onto the market. It is noticeable that the biosimilar industries are not impressive
competitors as generics in the commercial area, the costs are hugely different, and barriers which
biosimilars are facing are so large to be easily overcome (Grabowski, and Salgado, 2014). So, a
perspective in terms of economy, potential opportunities and possible threats will be presented in
order to analyse how the biosimilars are different or similar to the generics path onto the market.
A background of the generic evolution onto the market has supported the opinion which
is expressed in this research. In this part, the quantitative method is essential because it will show
statistics. The numbers here have assessed the cost and sales by years /countries.The generics
have encountered lots of barriers, such as efficacy and bioequivalence issue in the past and have

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been striving to grant a marketing authorization. Generic drug industries have been impeded for
around fifty years to fulfil a remarkable success. Consequently, how about biosimilars? The main
problem is: will biosimilars persist as a generic to compete with the market?
SWOT Analysis
In this review, a SWOT (strength, weakness, opportunity and threat) analysis is
conducted on biosimilar marketing. It is the best approach to identify how this biotechnological
medicine is promoted by pharmaceutical companies in emerging countries like BRICS (Brazil,
Russia, India, China and South Africa) or in MENA (The Middle East and North Africa)
countries.
The method of SWOT analysis is a tool, not a process such as opportunity analysis,
strategic planning and competitive analysis. It is used as a tool in order to structure a specific
session of brainstorming. As a result of using this tool, the process or issue that is being
investigated with the help of using the SWOT analysis tool might be taken in terms of a life
cycle or phases.
Ethical issues:
It seems that my project is not requiring ethical approval. However, if I would like to
conduct a research on internet communities ,providing questionnaires or involve human
participant and use it as qualitative data that will be an issue. It could be as the informed consent.
The term ‘Ethics’ refers to the basic concepts and moral values of decent human
conduct . Increasingly, ethical issues invade the public debate in various fields, including the
research in health sector. But this notion of ethics is ambiguous and does not have the same
meaning for all. For example in Tuskegee research , the informed consents was not provided to
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the subjects and has created a tragedy in human race. It is true that ethical issues are multiples in
a research such as Plagiarism, confidentiality, privacy, anonymity, protection of safety and
vulnerable population, dignity, informed consent, cultural variation and religion beliefs
complicate more the enrollment of research in some population and regions especially in social
works.
However, in my study I will come across qualitative and quantitative data provided in the
past and then analyze to finally make an opinion and proper conclusion with strong
recommendation . In addition, the document provided to Research ethics committee has not
been completed due to the ethical approval which is not required . These documents are long and
complicated when the researcher read them , he is reticent to conduct the study or motivated to
change the topic. On the other hand, I think that the human body participation in some studies
have to be approved.
Conclusion
The availability of biosimilars will certainly not enhance competition as generics onto the
market because the global players will not ruin the wall which are building against biosimilars,
they have learnt from the generic experience, they will probably develop their own follow-on
originator and invest in emerging market. Consequently, biosimilars will probably be the second-
largest source of growth but questions still remain over regulatory requirements. Regarding these
issues multiples studies has been conducted to analyse the challenges versus opportunities of
biosimliars. While the predictions on the economy of advanced countries are not promising, the
possibility of biosimilars submersion onto the market as generics small molecule is not excluded.
As in 2008, the financial crisis will probably occur and will impact on the emerging countries.
Moreover, the generics commercial expansion in that critical period had a considerable impact
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on the budgets and the available funding for health services. So, if the biosimilars benefit from
this predictable crisis, its competition onto the market will probably resemble the one of
generics. However, the assumptions are not reliable, they are needed to be substantiated in a
serious research project.
CHAPTER IV COMMERCIAL ISSUES
Introduction
The continuously growing expenses of health care and enhancements in the knowledge of
the different components that assume a role in the production of biotech therapeutic medications
have powered the push for authorisation of biosimilars (denoted to as follow-on products of
protein in the U.S.). Investigation and determination of the different scientific and administrative
variables behind the endorsement of biosimilars are maybe the most noteworthy events in the last
decade for biotechnology (Hirsch & Lyman, 2011). Justifications behind this are numerous. For
one, biotech procedures, as well as products, are unpredictable, keeping in mind the business has

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made huge improvements in the comprehension of how the procedure impacts the product and
significantly more should happen (Miletich, Eich, Grampp and Mounho, 2011).
Biosimilars are at various phases of development over the globe. Because of variable
rules and different guidelines learned all over, meanings of biosimilars fluctuate. Geographically,
the market for biologics in addition to biosimilars could be characterised in three major groups.
The first group is the US, the second is of regulated markets that include Japan, Canada, and
Europe; and the third group is related to emerging markets for pharmaceuticals which include
India, Brazil, China, Mexico, and Russia. With regard to Europe, it is one of the most advanced
nations and is mostly accounted for most of the worldwide spending. Regardless of a solid
legislation, there are not very many producers who have thought of biosimilars in the region of
Europe, till today (Hirsch & Lyman, 2011).
Market position of Biosimilars
With regards to biosimilars, they are lawfully affirmed consequent versions of visionary
biopharmaceutical products taking after patent and exclusivity expiry. In any case, the definition
and terminology of biosimilars vary among the different regulatory agencies worldwide.
According to Dranitsaris, Amir and Dorward (2011), Korean Food and Drug Administration
(KFDA) and EMA referred to biosimilars as similar to biological medicinal products. Also, the
US FDA and Ministry of Health Labor and Welfare called it as “follow-on biologics” as well as
“follow-on protein products”; however, Health Canada referred to biosimilars as “subsequent
entry biologics”. In addition to this, the biological drugs tend to contribute to one of the largest
sectors in the global pharmaceutical industry (Dranitsaris, Amir & Dorward, 2011). In the
previous year, the biosimilar sales were recorded nearly US $1.9–$2.6 billion. Also, in the year
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2020, the growth in the industry is expected to reach a compound annual growth rate of 7.7%
with the US $25 billion (Bhushan, 2014; Lai, Antonini and Murphy, 2015).
With regards to its classes, the products of biosimilars consist of various therapeutic
classes such as interferons, erythropoietin, low molecular weight heparins, growth hormones, Fc
fusion proteins, monoclonal antibodies and insulins. Among these classes, the major product
class established is monoclonal antibodies that tend to occupy a major portion of the biosimilar
market space. As stated by Lai, Antonini and Murphy (2015), the reason behind this is the
success of therapeutics of such molecules in addition to the prevalence of such diseases including
psoriasis, arthritis and cancer. For top-selling monoclonal antibody drugs, the patents which are
poised to expire in short time period or even if they are expired already, there has been a demand
among the producers of biosimilars in the business around the globe. Two major reasons,
biosimilars are effective for healthcare in this manner are that the first one is related to the
accessibility of non-costly drugs, and the second reason is the focus for development of new and
improved biologics. In order for their product registrations, sponsors of biosimilars required
proving similarity or even equivalence to the reference product (Gautam and Pan, 2016).
Varieties of smaller size, particular dangers of immunogenicity, must appear as clinically non-
significant, on account of security and viability. These administrative pre requisites have now
developed and been incorporated into the rules and policies.
Contrasting Emerging Markets and Old Players in Biosimilars
Around the globe, biosimilars are at various stages. Because of the differences in
regulations as well as guidelines that are practised around the world, there are many definitions
of biosimilars that differ across many regions and countries. Europe has been one of the most
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progressive and advanced economies that accounted for most of the global spending. Regardless
of the strong regulations, there have been few manufacturers who came up with the biosimilars
in the same region (Simoens, 2011). Among those players, most eminent included in the
European Union are Stada, Hospira, Sandoz/Novartis, Teva and Medice. Across Europe,
biosimilars are established in three major areas of therapy that include HGH, G-CSFs for
lowered white blood cell counts after chemotherapy, and EPOs for the treatment of anaemia
caused by renal dialysis. On the other hand, countries such as France and Germany accounted for
half of the EU market. In addition to this, Simoens (2011) stated that other regions such as UK,
Holland, Italy, and Spain required are catching up to this. However, those countries that fall
under the category of emerging economies include Brazil, India, and China which have
developed and maintained their own pathways for regulations so that they could effectively
manage the approval of biosimilars (Gautam and Pan, 2016).
These developing markets have kept lower hindrances for clinical trial requirements and
also administrative control opposite the EU. Lesser stringent structures have offered an approach
to modified biologics in the oncology and also EPO markets particularly in nations like China.
Comparable patterns are being followed in India and Mexico. A progressively expanding stream
of new patients in the developing economies would require the development of biosimilars
market in the short run. In any case, in the years to come, the US would certainly be the key
worldwide market for biosimilars (Gautam and Pan, 2016).
Growth of Biosimilars in Emerging Markets
As the worldwide biosimilars market keeps on developing, emerging nations assume an
undeniably significant development. Many emerging countries are setting up biosimilars

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regulatory pathways, giving sponsors a chance to select research destinations deliberately to
advance timelines of complete development and accomplish enrollment objectives. On the other
hand, regulatory and operational obstacles remain (Rovira et al, 2011; Azevedo, 2010). The
implementation of studies over nations with changing controls includes layers of complexity, yet
these difficulties can be overcome with top to bottom learning of every local environment and
early strategic planning. Looking towards the future, there is a pattern towards harmonisation of
reference product requirements. This is seen especially in the EU and U.S., with the probability
that both EMA and the U.S. FDA will allow the utilisation of clinical information with reference
products enrolled in each other's local in market applications. In this way, it may not be
important to direct global reviews that incorporate comparators from every market on the
condition that there is adequate logical and administrative rationale (Chakma, Sammut and
Agrawal, 2013). Despite this, such criteria are yet to be resolved. There is an impact of EMA and
U.S. FDA administrative examples, such a move would likely prompt harmonisation universally
in the long term. Indeed, Rovira et al (2011) stated that rules from a few nations in developing
countries, exceptionally Singapore, Malaysia, India, Saudi Arabia and Egypt (and additionally in
Canada and Australia, as they generally imitate EMA guidance), as of now give a specific level
of similar harmonisation in prerequisites. They even incorporate adaptability with regard to
information created with reference products enlisted outside their jurisdiction if such products
are advertised in key reference markets as well as meet certain requirements.
Up to now, 14 biosimilars have been authorised to be marketed in the EU. In spite of
their lower cost (20% to 35% which are less than their branded counterparts), the acceptance and
utilisation of biosimilars in the EU have not exactly been anticipated (Chakma, Sammut and
Agrawal, 2013). Nevertheless, the continuous global financial downturn, soaring social insurance
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expenses, and patent expiry by 2018 of biologics with yearly sales in abundance of $67 billion
have provoked a re-established worldwide enthusiasm for biosimilars, particularly in emerging
markets. In addition to this, the developing popularity of biosimilar products in emerging
markets can be clarified by various elements. To start with, the high cost of exclusive biologics is
putting enormous financial weighting on the nationalised health care framework of many
emerging nations. Firstly, according to Chakma, Sammut and Agrawal (2013), replacing lower-
cost biosimilars for exclusive biologics would diminish government medicinal services costs and
decrease the financial weight of insurance agencies and third-party payers. Second, countries like
China, Brazil, and Russia are to a great degree reliant upon foreign biologic makers and
providers for some biological products.
Previously, this had frequently brought about deficiencies, rising medication costs, and
diminishments in patient access to possibly life-saving medications. Finally, biosimilars speak to
an opportunity for emerging economies to manufacture local biologics and biotechnology
capacities which, consequently, would permit them to infiltrate and even more successfully
contend for a share of the global pharmaceutical and biological markets (Mellstedt, 2010).
Changing Forces Shape Growth of Biosimilars
While biosimilar organizations in emerging markets share certain benefits over their
partners in more developed markets, including lower work costs, less expensive costs of
products, access to substantial household and local markets, and as a rule, increased government
support and contribution, can shift the development of a biosimilar industry in developing
markets amongst countries as well as regions (Tkaczuk and Jacobs, 2014). This surely is valid
for the biosimilar ventures that have developed in Brazil, Russia, India, China, and South Korea.
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Since the market flow that shaped the biosimilar enterprises in each of these nations is distinct in
their business systems, practices, and objectives (Cornes, 2012).
In 2010, Brazil's regulatory agency, Agencia Nacional de Vigilancia (ANVISA), made
another regulatory endorsement pathway for biosimilars such as RDC 55/2010. On the other
hand, since the mid-2000s, biosimilar variants of erythropoietin (EPO), granulocyte state
invigorating element (G-CSF), and insulin have been accessible in Brazil. Interestingly, in 2011,
almost 20% of biological medications recommended in Brazil were biosimilars (Tkaczuk and
Jacobs, 2014). In the same way as other rising countries in the world, Russia's dependence on
high-priced international biologics is developing and is creating a tremendous financial strain on
the nation's nationalised health care framework. In view of this, the Russian government is
exceptionally open to dialogs about substituting lower-cost biosimilars for high-value biologics
(Tsuruta, Lopes dos Santos and Moro, 2015).
In contrast, China does not have any regulatory framework set up for endorsement of
biosimilar items until the year 2013. Biosimilars can be permitted in China utilising its
traditional biologics endorsement pathways, which can take numerous years due to the Chinese
regulatory organisation. In 2009, another emerging economy South Korea made and
implemented a regulatory framework structure for approval of biosimilars. Presently, the South
Korean government declared an aggressive action to endeavour to catch 22% of the global
biosimilar advertising by 2020 (Megerlin, Lopert, Taymor & Trouvin, 2013). Dissimilar from
India, Brazil, Russia, and China, which are centred on regional markets, the primary goal of the
Korean initiative is to become one of the leading global as well as regional biosimilar producers
and exporters during the following 5 to 10 years (Tsuruta, Lopes dos Santos and Moro, 2015).

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Opportunities and Challenges for Biosimilars in Emerging Markets
There are a small number of areas with regards to the pharmaceutical market more
eagerly discussed than biosimilars, yet the pathway to building up a viable worldwide product
market place is not clear. According to Megerlin, Lopert, Taymor and Trouvin (2013), interest in
biosimilars is being driven by the potential offered by a scope of high-value brands which will be
liable to patent difficulties in the next 5-10 years, for example, Roche's Herceptin® and
Avastin®. On the other hand, Megerlin, Lopert, Taymor & Trouvin (2013) stated that the US
market remains the leaders for biosimilars, however, they slowed down with an unproven
administrative process. Europe is more pioneering, however, there are important obstacles to
market entry. Thus, it is nothing unexpected that developers of biosimilars are fluctuating to
developing markets as a preferred market entry point (Liang, 2012).
In addition to this, the basics of biosimilars in emerging markets are sound. The clinical
need in substantial and expanding populaces, developing GDP and health spending, expanding
patient expectations and frequently agreeable regulatory regimes all give a rich domain to
biosimilar products.
Liang (2012) also stated that numerous biosimilar organisations in developing markets are
creating systems and unions outside of the US and Europe which are giving profitable income
and information of global trade. For new participants, biosimilars position altogether different
difficulties to those introduced by smaller molecule generics, with even more demanding
requirements as far as clinical advancement, access to market, manufacturing and sales and
marketing capabilities (Roger, 2010). These can be numbered as follow:
High costs for development: With regards to the development of biosimilars, one of the
major challenges is related to the high cost of its development because it is not
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considered as the simple process. However, this process requires significant investment,
clinical trial expertise, as well as technical capability. The normal estimates of costs
range from US$ 100 to 250 million, in case the development of a plant is also required.
However, if the development of a plant is not required, then the cost would range from
US$ 20 to 100 million.
Issues in manufacturing: There have been many obstacles in the development of
manufacturing capability of biosimilars that are not highly priced (Roger, 2010). Their
development also included refined processes as well as technologies that increase the risk
of investment to biosimilar manufacturing capability.
New regulatory framework: Apart from Europe, the framework for the regulation of
biosimilar in most markets has been generally new compared to the well-established
process of approval for the NCEs, in addition to the small generic molecules. However, it
is non-existent in some cases that have increased the riskiness of global investments.
Branded approach: Winning the trust of partners will require a large portion of the
resources, skills, and branded attitude of an ordinary inventive pharmaceutical
organisation, possibly including changes to business models (Krishnan and Jha, 2011).
Activities to ease concerns related to safety among doctors and patients will be especially
critical, maintained by sales groups with more profound medicinal and technical learning
specialist. This would require interests in the sales and marketing segment to begin with,
which should be possible through inner sources or by means of other marked
organisations (Krishnan and Jha, 2011). Two other key components would be an
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investment in pricing followed by the access to the market. More specifically, post
advertising surveillance has been made obligatory in Europe with the US to follow this
(Krishnan and Jha, 2011; Roger, 2010).
INNOVATIVE PRICING MODELS:
In emerging markets that have low reimbursement rates and patients with limited ability
to pay for treatment, the primary barrier to access is price. Local biosimilar companies
with smaller cost bases scaled across broader portfolios can compete at very low prices.
But both they and multinationals need to adopt innovative pricing models to treat large
numbers of patients while maintaining profitability.
For such pricing models, biosimilars can take a page from the book of their originator
counterparts. Roche’s Herceptin in China provides a notable case of a company that
tackled the affordability gap to expand opportunities for patients. The treatment rate for
HER2-positive breast cancer was about 20 to 25 percent when the company cut the
drug’s price considerably so that it could be included in the national reimbursement list,
which is expected to spur a sharp rise in the use of biologic treatments. If the treatment
rate were to reach that of the United States—about 70 percent—up to 30,000 additional
HER2-positive breast-cancer patients would receive treatment every year.
The classic tactics of discounts and price reductions are not the only ways to address the
affordability barrier. Other options include these:
Patient-assistance programs. In these programs, manufacturers offer medicines at
reduced prices to patients who can’t afford the full ones. In Novartis’s cost-sharing

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program for Gleevec, for example, the patient pays for the initial treatment, and the
company contributes to the cost of subsequent cycles, depending on the patient’s ability
to pay. This approach supports market penetration, provides therapy comfort, aids the
development of guidelines, and helps create a “reservoir market” that may in time be
converted to market-price sales, especially in the case of longer therapies for chronic
diseases.
Microinsurance. These are collaborations between biosimilar manufacturers and local
insurance companies to provide policies offering patients affordable care. Pfizer, for
instance, has recently announced a partnership with People’s Insurance Company of
China to offer patients in China pay-for-performance insurance for cancer treatments.
Microfinance. This is a way to offer payment by installments. In markets with high out-
of-pocket payments, experiments with microfinance have extended patient access in areas
such as fertility and infectious diseases.
Dual branding. This is a way for manufacturers to launch the same drug under different
brands at different price points to target different affordability segments. Roche adopted
this strategy in launching a second brand of Pegasys in Egypt. Pegferon was packaged
locally and sold to the government at a lower price, giving 160,000 patients access to
quality treatment and enabling sales of Roche’s hepatitis C portfolio to rise to $90 million
in Egypt, from less than $10 million, in under five years. Beyond biologics, Sanofi
addressed malaria in sub-Saharan Africa by launching a fixed-dose combination
treatment through the WHO prequalification program at a lower price than it charges in
private markets.
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Addressing the affordability gap is critical to success in emerging markets. Companies first
assess reimbursement levels and segment the market at a granular level, by disposable income
and out-of- pocket spending. Using the mechanisms described above, companies can then design
targeted pricing models for each product and country.
Multinationals must heed measures adopted by some emerging markets, where prices are
regulated in exchange for investments to improve the local industry. Brazil, for instance, has
implemented production-development partnerships (PDPs) that allow multinationals to access its
market if they transfer some of their technology and reduce their prices by up to 60 percent,
usually with the expectation of further price reductions of 3 to 5 percent a year thereafter. The
long-term stabilizing effect of such arrangements could benefit pharma companies, patients, and
health systems. Multiparty agreements among multinationals, local pharma companies, and
public institutions can be difficult to reach, however, slowing time to market. Multinationals will
also need to weigh the benefits and risks of technology transfer carefully before committing
themselves.
Differentiating beyond price
Competing in emerging markets means competing in a price-driven environment. Besides
adopting innovative pricing strategies to address affordability, biosimilar companies must also
seek to differentiate themselves to preserve profitability and encourage switching in markets with
lower-priced alternatives. Some companies have capitalized on their investments in developed
markets to pursue strategies such as these:
Implementing detailed plans to control the supply chain to preserve above-par flexibility and
reliability. Biosimilar manufacturers, which have repeatedly experienced stockouts in emerging
markets, could learn lessons from other market segments (such as vaccines) by, for instance,
using contract manufacturing organizations (CMOs) to add short-term capacity quickly in
response to unexpected demand.
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Introducing support programs for patients and healthcare professionals:This approach could
include training patients to administer their own treatments, providing call centers staffed with
nurses, arranging home visits by nurses, or using texts, mobile apps, or social media to send
patients reminders to encourage adherence.
Using real-world evidence from early-launch markets in the European Union and the United
States. In markets with limited experience of quality biosimilars, this approach helps companies
to build trust in a treatment’s safety and efficacy among payers, patients, and physicians.
Building a robust body of clinical evidence with interchangeability-trial results and transition
data. Using this approach, companies can provide evidence of safety, immunogenicity, and
efficacy following a switch from the reference product.
Offering alternative delivery mechanisms or pain-free formulations administered in a more
patient-friendly way than the originator drug or other biosimilars. Subcutaneous injection or
inactive formulation ingredients with lower pain scores are two examples.
Marketing companion diagnostics and high-quality self-injection devices.If these are easy for
patients to use, they can unlock access to remote populations.
Pushing for the inclusion of value criteria Although tendering and contracting in developing
markets revolves around price, companies often have scope to shape the selection criteria. For
instance, in a market (such as China) with hospital tenders, companies can engage with
pharmacists and formulary committees to push for the criteria to include clinical evidence on
switching, self-injection devices, or training support for patients and healthcare professionals.
This approach is particularly relevant for biosimilars competing in higher-price segments and
striving to avoid being locked out of tenders against local competitors with lower price

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Build local partnerships All emerging markets are different, so the range of winning models is
wide. Local companies such as Reliance Life Sciences (in India) and CP Guojian (in China) have
capitalized on their local footprints to commercialize biosimilars or biologic alternatives in their
home markets. CP Guojian developed Yi Sai Pu (a biologic alternative to etanercept) in house,
launching it in 2006—ahead of Enbrel, the originator product. Revenues from Yi Sai Pu,
growing by about 10 percent a year, reached roughly $150 million in 2017.Some companies in
emerging markets have expanded beyond the home markets. India’s Biocon has launched insulin
glargine in more than 20 emerging markets, including Malaysia (through CCM
Pharmaceuticals), Mexico (PiSA Farmacéutica), and Algeria (Abdi Ibrahim). Similarly, Dr.
Reddy’s has launched its rituximab biosimilar Reditux in Chile, Ecuador, Peru, Russia,
Venezuela, and Vietnam and recently obtained approval for it in Turkey.
Many multinationals form partnerships with local players to enter emerging markets—for
example, Sandoz with Biocon (India), Sanofi with JHL Biotech (China), Celltrion with Hikma
(Middle East and North Africa), or Janssen in a PDP with Bionovis and Bio-Manguinhos
(Brazil). A partnership with a local company is often the best route to rapid penetration for a
multinational, helping it to navigate complex regulatory environments, to build on existing
relationships with government bodies and customers, and to reduce manufacturing costs. For
local companies, such partnerships can be a good way to boost growth by capitalizing on their
market position and local knowledge. For multinationals that want to preserve their options while
learning from organizations geared to local needs, licensing biosimilars to local companies or
striking comarketing deals may be the preferred choice.
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China represents a prime case of the need to collaborate with local partners, since local
knowledge and relationships are crucial in gaining access to patients for clinical trials, securing
regulatory approval, navigating the reimbursement process, and building relationships with local
stakeholders for commercialization. Amgen, for example, has collaborated with Simcere to
develop and commercialize four biosimilars for treatment of inflammation and oncology in
China, and Samsung Bioepis recently announced partnerships there with C-Bridge Capital and
3SBio to commercialize several biosimilars.
More recently, some multinationals have begun to invest in local contract manufacturing
facilities. In 2017, for instance, Boehringer Ingelheim opened a new facility in Shanghai to
develop and manufacture biologics and biosimilars for the Chinese market on contract for local
companies and other multinationals. Similarly, Lonza recently announced plans to establish a
biologic CMO site in China. As the demand for quality biologics and biosimilars increases, more
biosimilar manufacturing collaborations between foreign and local players can be expected.
Emerging markets with low biologic-treatment rates and affordability barriers that impede
patients’ access to expensive, innovative medicines present attractive opportunities for
biosimilars. To benefit, pharma companies should be smart, entering countries with supportive
regulatory frameworks, employing innovative pricing models, differentiating themselves to build
sustainable share, and collaborating with local partners. They should also set clear long-term
objectives, adapt their business models to the markets they target, and build agile organizations
that can respond rapidly to local needs, for time is of the essence: patients in emerging markets
cannot wait decades for the biosimilar market to mature or for affordability barriers to disappear.
Just as the telecom industry in many developing countries skipped landlines, leapfrogging
straight to the mobile internet, so too could the biosimilar industry advance in leaps and bounds
to offer affordable, high-quality biologic therapies that close the treatment gap between the
developing and developed worlds.
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Chapter V : Analysis of Regulatory environment
Whilst biological medicinal products are usually expensive and represents ever-increasing
pharmaceutical expenditures, biosimilars are less costly and more fastidious in terms of
regulation. So, biosimilars are greatly impacted by the policies and regulations.

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Firstly, as it is aforementioned, the squeeze caused by the brand companies may interfere the real
job of the regulator and let him make wrong or unfair decision against small companies which
produce biosimilars. Secondly, the interchangeability issue which could pose serious public
health problems, with important commercial consequences. Because doctors will likely not feel
confident switching patients from a non interchangeable biosimilar to a reference product or
another non interchangeable biosimilar (Rotenstein et al.2012).Thus, how regulators are implied
in this issue ? The answer is certainly the comparability exercise which is required to ensure the
efficacy and safety of the product. Conversely, state laws barring substitution may have an
impact on "free market competition". Finally, the basis for the regulation on biosimilars is to
recess the high price of biologic therapies by reducing the cost of their clinical development.
Manufacture and quality control of biologics is equally expensive for originator and biosimilar
companies; it may even be more burdensome and expensive for a biosimilar company, since the
biosimilar has to be technically developed to closely resemble its reference (EGA 2011). In this
case, the regulator is cornered by his own rules.
Therefore, the contribution of regulations has an important role on the sustainability of the
biosimilar medicine market. On the one hand, it may have a good impact by promoting the
competition and increase the trust of stakeholders. On the other hand ,it may have a very bad
impact by declining the sustainability of the biosimilars and lead to an unfair return in
investement (RIO) ( EGA, 2014). The regulatory issue is the main barrier of biosimilars
introduction and evolution onto the market. Meanwhile, policy makers are struggling with an
inherent conflict between desire to provide improved access to better medicines and the need to
curb the growth of healthcare expenditures. These elements seem to highlight that biosimilar
competition may resemble more that of me-too pharmaceuticals than that of generic medicines.
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regulatory assessment
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To gain access and develop a sustainable share, companies need to prioritize markets with a
maturing regulatory environment and policy incentives that create a supportive environment for
biosimilars. Most emerging markets that have such a regulatory framework have modeled it on
those of the World Health Organization (WHO) or the European Medicines Agency
(EMA).Brazil and China have created solid frameworks, including accelerated approval
pathways and strict requirements for evidence of biosimilarity. In Brazil, more than 10
biosimilars have been approved since its biosimilar pathway was established, in 2010. Although
China did not experience an immediate uptake of approvals for biosimilars under its new
pathway, a number of them are expected launch in the next few years, after the recent reforms of
the Chinese healthcare market. Other countries—including Egypt, India, Indonesia, Mexico,
Russia, Turkey, and Vietnam—have also defined biosimilar comparability pathways, although
they have yet to be implemented effectively everywhere.Some of the biologic alternatives
commercialized in emerging markets have been developed without recourse not only to high
standards for biosimilarity but also to analytical or clinical investigation. Dealing retrospectively
with these products remains a challenge. In India, for instance, more than 70 approvals have been
granted in the past 25 years, mostly to local manufacturers, while quality standards were not yet
fully harmonized. Such conditions make markets less attractive for entry and partnerships, as the
barriers for entry may be too low to support adequate returns for companies investing in dossiers
in several countries.Over the next ten years, as regulatory environments mature, we expect the
biosimilar markets in many developing economies to stabilize—particularly in Brazil, China,
Egypt, India, Indonesia, Malaysia, Mexico, Russia, Turkey, and Vietnam. These countries
collectively represent more than eight million new cancer patients a year.With this in mind,
companies evaluating opportunities in particular countries should pay close attention to their

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market and regulatory maturity, as well as the individual asset requirements. That involves
examining treatment rates, channel options, and the impact of legacy products approved before
regulations matured. At the portfolio level, companies choosing to invest in one or another asset
should be prepared to make conscious trade-offs between the ease of getting approval and the
cost of assuring quality.
H5 regulatory authorities develop a specific, appropriate, regulatory framework for approving
biosimilars that is distinct from the regulatory procedures previously applied to copy-version
products, where regulatory evaluation was not well-defined. Communication and education of
patients is also highlighted as important. As part of this communication, publication of public
assessment reports on biosimilars is recommended as a way to increase transparency and
increase public trust in biosimilars.http://gabionline.net/Biosimilars/Research/Biosimilars-and-
the-role-of-regulatory-authorities
H6 the cumulative scientific knowledge was raised and the evaluation criteria became more
stringent To address the gap in knowledge in regulatory sciences, such as the critical thinking
model and the principles and criteria required for the evaluation of biotherapeutics, COFEPRIS
MEXICO was established a Center for Excellence in December 2016. This initiative aims to
invest in regulatory a airs training programsff
H7 National databases or registries to record details of biological switching, particularly adverse
event profiles, so as to obtain safety data
post-switchinghttp://gabionline.net/Biosimilars/Research/Recommendations-for-biosimilars-in-
rheumatology-in-the-Middle-East
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H8The Malaysian Government is heavily subsidizing public healthcare expenditure in order to
provide access to health care for all citizens. In 2017, total healthcare expenditure in the country
was approximately 9.4% of the annual budget. In order to overcome the increasing cost of health
care, the government has implemented a National Generic Medicine Policy in 2006 to promote
healthier competition in medicine pricing and to make medicines more affordable to the general
public. After 10 years of policy implementation, authors from the Ministry of Health Malaysia
assess patients' beliefs about generics.http://gabionline.net/Generics/Research/Mixed-beliefs-
about-generics-among-patients-in-a-Malaysian-hospital?
utm_source=GONL6&utm_campaign=a87e3d545e-GONL+V19E03-
6&utm_medium=email&utm_term=0_bfb08b6fa4-a87e3d545e-143119457Policymakers in
Europe should introduce a long-term, multi-stakeholder framework to realize the full potential of
off-patent biologicals and biosimilar drugs, according to the results of a series of roundtable
discussions held with clinicians, government bodies and industry representatives [1].
When the patent on a biological drug expires, biosimilar versions can enter the market. In
Europe, the quality and safety of these products is regulated by the European Medicines Agency
(EMA).http://gabionline.net/Biosimilars/Research/How-can-EU-policymakers-access-the-
potential-of-biosimilars]
http://gabionline.net/Biosimilars/Research/Comparison-of-Brazilian-regulations-for-follow-on-
biologicals-with-EMA-FDA-and-WHO
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H9The World Health Organization (WHO) has emphasized the importance of communication,
trust and education in order to increase patient access to biosimilars in high-income countries.
The issues were discussed by Emer Cooke, Head of the Regulation of Medicines and other
Health Technologies Department, at the 17th Biosimilars Medicines
Conference.http://gabionline.net/Reports/WHO-says-more-communication-and-education-
needed-to-increase-access-to-biosimilars?utm_source=GONL6&utm_campaign=a87e3d545e-
GONL+V19E03-6&utm_medium=email&utm_term=0_bfb08b6fa4-a87e3d545e-143119457

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India has a thriving biosimilar ecosystem in comparison to other countries and because of that
Indian pharmaceutical companies have risen as the global market leaders in biosimilars. India
approved its first biosimilar much before the United States and Europe. The first biosimilar was
approved and marketed in India in 2000 for hepatitis B, although no specific guideline was
available at that time for the development and marketing of biosimilar in India.[22] Since then
several biosimilars were developed and marketed in India by various biopharmaceutical
companies.[22] Recently, an Indian biopharmaceutical company got the USFDA’s nod for
marketing its novel biologic. Herceptin (active drug is trastuzumab) was the first biologic to be
approved by FDA, which is used in certain breast and stomach cancer. This was also the first
similar biologics manufactured by an Indian company, which received approval to market in the
United States. Presently, there are more than 100 Indian biopharmaceutical companies, which are
engaged in manufacturing and marketing of biosimilar. Biosimilar is called as “similar
biologics” by Indian regulatory agencies. No specific guideline was available for “similar
biologics,” despite the fact that India was one of the first countries in the world to use it, and
approval process of similar biologics is more cumbersome and require more data than other
generic drugs. To address the issues and challenges associated with the development of similar
biologics, Central Drugs Standard Control Organization (CDSCO) in collaboration with the
Department of Biotechnology (DBT) has developed “Guidelines on Similar Biologics;
Regulatory Requirements for Marketing Authorization in India” in 2012 and has revised it in
2016.[23],[24],[25] These guidelines address the regulation of manufacturing process as well as
quality, safety, and efficacy of similar biologics. It also addresses the pre- and post-marketing
regulatory requirements for similar biologics. DBT through Review Committee on Genetic
Manipulation is responsible for overseeing the development and preclinical evaluation of
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biologics. The similar biologics in India are regulated as per Drug and Cosmetic Act (1940),
Drug and Cosmetic Rules, 1945, and Rules for Manufacture, Use, Import, Export, and Storage of
Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989 (rules, 1989)
notified under Environmental (Protection) Act,1986.[23] CDSCO has brought some important
changes in its earlier guideline, such as earlier it was essential for the reference biologic for
which biosimilar is to be developed has to be approved and marketed in India but it has now
changed to either India or any other international council for harmonisation countries (i.e.,
European Union, Japan, United States, Canada, and Switzerland). It also tries to align with other
international agencies such as EMA and the World Health Organization. According to Indian
guideline, biologics are developed by the sequential approach to show the similarity of the
molecular and quality characteristic of a biosimilar with reference products. Another difference
between the 2012 guidance and the document issued in 2016 is the emphasis on the post-
marketing studies, which CDSCO says are intended “to further reduce the residual risk of the
similar biologic,” CDSCO has made it essential for the biopharmaceutical company to conduct a
Phase IV study with a minimum of 200 patients within 2 years of getting approval for marketing.
[23]
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The regulator also added a new section on non-comparative safety and efficacy studies, noting
that if a product is found to be similar “in pre-clinical, in vitro characterization having
established PK (pharmacokinetic) methods and a PD (pharmacodynamic) marker that is
surrogate of efficacy, the residual risk is significantly reduced in the Phase I study if equivalence
is demonstrated for both PK and PD. Phase III clinical trials of such a Similar Biologics product
may be waived...[and] where considered necessary, an appropriate single arm study in at least
100 evaluable subjects may be carried out in the most sensitive indication to address any residual
uncertainty.”
CDSCO also added new information on when a confirmatory clinical safety and efficacy study
can be waived, noting: “In case the safety and efficacy study is waived all the indications
approved for reference product may be granted based on comparable quality, non‐clinical as well
as convincing PK/PD data. Wherever the Phase III trial is waived, the immunogenicity should
have been gathered in the PK/PD study and will also need to be generated during post-approval
Phase IV study.”
Indian companies are taking multiple steps to involve them in manufacturing and marketing to
tap this huge potential. Biosimilars approved and used in India mainly consist of the vaccines,
monoclonal antibodies, insulin, and recombinant proteins. India has achieved the distinction of
being the second largest supplier of vaccines in the world. Various biosimilars have been
approved by India for use in different diseases.
Future Perspectives

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Many companies will have their patent expire in the forthcoming year, which will open the
window of opportunity for other biopharmaceutical companies to explore the possibility of
development of biosimilar products. The global market for the biosimilar is expected to grow by
US$10 billion and many companies are anticipated to enter into this lucrative sector.
Although the biosimilar space is still growing and evolving in the United States, India is a
significant player in the world in manufacturing and using of biosimilars.[26] Indian biosimilar
market was approximately US$300 million in 2015. The domestic sales are close to US$250
million and growing at a compound annual growth rate of 14%. The export of biosimilar or
similar biologic from India stands at a staggering US$51 million.[18] India has the potential to
become a global player in similar biologics or biosimilars. According to ASSOCHAM-Sathguru
report released in 2016, biosimilar presents a US$240-billion global opportunity to Indian
biopharmaceutical industry and the domestic market is expected to grow US$40 billion by 2030.
[27] Institute of Medical Sciences’ health-care report also envisages a similar opportunity for
Indian biopharmaceutical companies associated with manufacturing and marketing of
biosimilars.
Conclusion
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Biosimilars hold promise to improve patient’s accessibility for many malignant and
nonmalignant ailments by reducing the treatment cost. Since the use of the first biosimilar, the
development and uses of “biosimilars or similar biologics” have witnessed substantial growth.
Every year, regulatory agencies are granting approval of various similar biologics for the
treatment of many cancerous and noncancerous diseases. India has firmly established itself as a
global player as a maker of similar biologics. It is also a huge market for the similar biologics
because of its burgeoning population. Although the potential is high and expectation is huge for
India, the challenges are also enormous and daunting to maintain the leadership. To achieve the
true potential and continue as a global leader, Indian biopharmaceutical companies need to
upgrade their technology and have to improve the manpower skill. For this, they need an
enabling environment from the government and regulatory agencies
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APPENDIX :PRE-PILOT Study : ANALYSIS OF FINDINGS AND DISCUSSION
External Research: Online Survey
Online surveys were conducted where respondents were asked in a questionnaire about
the growth of biosimilars in emerging economies. The responses gathered from the online
surveys are illustrated below.
Q1 - Which department /sector do you work for?
Answer Choices Responses
Regulatory Affairs 66.67%
10
Quality Assurance 20.00%
3
Clinical Trials
13.33%
2
Total 15
The first question in the surveys asked respondents was determining their respective
departments where they have been currently working. It was found that majority of the
respondents (66%) worked in regulatory affairs. On the other hand, 20% respondents worked in
quality assurance department while 13.3% worked in clinical trials.
Q2 - How do you qualify the region you work in?
Answer Choices Responses
Developed 31.25%
5
Developing 68.75%
11
Total 16
The second question in surveys was related to determining the region where respondents
are currently working. It was identified that 31.2% participants responded to the questionnaire

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belonged to developed countries. However, 68.7% respondents belonged to developing countries
or emerging countries.
Q3 - Do you work in Biotech Company?
Answer Choices Responses
Yes 37.50%
6
No 62.50%
10
Total 16
The surveys also determined whether respondents who participated in the study worked
in biotechnology company or not. It was found that 37.50% respondents currently being working
in a biotechnology company. On the other hand, 62.5% of total survey respondents who
participated in the study were not working in a company that deals with biotechnological
products.
Q4 - Which regions and countries present the greatest potential for the biosimilars
business?
Answer Choices Responses
The Triad 16.67%
2
BRIC 41.67%
5
MENA 41.67%
5
Total 12
One of the questions in the survey was related to determining the respondents’ point of
view about the countries and regions that presented increased potential for the biosimilar
business. Hence, the surveys found that the key attraction for doing biosimilar business is BRIC
countries and MENA countries as 41.6% respondents marked on these countries in the survey.
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After BRIC and MENA region, 16.67% stated that the Triad regions would be major attraction
for biosimilar business
Q5 - Does your company planning more capital investment this year than last year?
Answer Choices– Responses–
Yes 68.75%
11
No 18.75%
3
Not Sure 12.50%
2
Total 16
When conducting surveys, respondents were also asked whether their companies have
been planning for more capital investments in the current year as compared to last years. The
majority of the survey participants stated “Yes” according to 68.75% respondents who
participated in the surveys. In addition to this, 18.75% respondents stated that their companies
have not been planning for increased capital investments in the current year when compared to
last years. However, only 12.50% of total survey participants stated that they were not sure
whether their companies have been planning for increased capital investments in the current year
when compared to last years.
Q6 - Do you think that Biosimilars could be a key growth driver for your firm over the next 5
years?
Answer Choices– Responses–
Yes 37.50%
6
No 43.75%
7
Not sure 18.75%
3
Total 16
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As the major aim of the study is related to the concern of growth of biosimilars in
emerging markets; hence survey respondents were asked whether they think biosimilars could be
a key growth driver of their organisations over the next five years. Surveys have found that
majority of the respondents stated “No” that represented 43.75% of total survey participants. In
addition to this, only 37.50% respondents stated biosimilars could be a key growth driver for
their firm over the next five years. However, 18.75% were not sure about the biosimilar as a
growth driver in their respective companies.
Quantitative Research: SWOT Analysis
In the area of quantitative research, SWOT analysis is used as a tool to assess the growth
of biosimilars in emerging countries. The availability of biosimilars has presented emerging
economies with an attractive opportunity for those types of biotech organisations which are small
and have been searching for capitalising on the success of the originator of biotechnological
products that has efficacy as well as proven safety (Chan, Wong, Chan and Traini, 2014).
Following is the SWOT analysis for biosimilar growth in emerging economies which are
discussed in detail.
Strengths
One of the significant strengths of biosimilars is related to its lower costs which
differentiate it from other originator drugs. Hence, the cost structure of makers of biosimilars
should be submitted to this disagreement from early improvement through to marketing. The
subsequent difference relies on upon the innovative work beginning stages of every product. The
originator business is a research driven environment; there is no sure profit for every dollar

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contributed in light of the fact that the research target may demonstrate impracticable (Chan,
Wong, Chan and Traini, 2014). The biosimilars business then again is a research driven
environment, where a dollar is invested into a general improvement effort that has effectively
demonstrated its practicality. Development is a more measurable endeavour than research on
new drug leads.
Having a reference product with numerous years of improvement, manufacture and
market understanding as the foundation for the improvement of a biosimilar prompts to
significantly more measurable risks and rewards contrasted and venturing into research on new
medication leads. In a period where temporary financial objectives are critical, the calculability
of a venture is of increasing significance (Santi and Simoni, 2014; Mota, 2014). On the other
hand, the biosimilar industry could prove to be one of the most attractive choices for investors
wishing to enter the industry because of the calculability of the risks and rewards which might be
higher when compared to the researches of new drug leads. Hence, it is also expected that the
industry could have increased access to the sufficient sources of capital. On the other hand,
biosimilars are now considered as reality as compared to previous eras when its evolution was
not seen to be possible. In Europe, the first biosimilar was introduced in 2006 as a result of
which the view of an industry about the developing of a new class of medicines has shifted
dramatically. Though at first, the discussion was about whether the intimacy thought may prompt
to the foundation of another class of medications, today the discussion is considerably more
about when and how such biosimilars will drain incomes of originator medications (Mota, 2014).
On the other hand, the business is still establishing itself; even in the most developed regulatory
environment of Europe, there are still just a modest bunch of biosimilars available. The high
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number of originator biotech drugs detaching the patent sooner in the prospects; besides, pulls a
constant series of biosimilars onto the industry (Betteridge, 2014).
Weaknesses
Apart from major strengths of the use of biosimilars in addition to its industry,
biosimilars are not without any weaknesses. Even though biosimilars are considered as
analogous to the innovator product, it is not identical. Hence, one of the weaknesses is related to
its safety which is one of the major issues for biosimilars. There are many factors contribute to
the safety of any biotechnological product (Christodoulou, 2014). During the phase of production
of the duplication that is biotechnologically developed, any of the slight changes during the
manufacturing method such as modification in the enzyme used, change of cell line, or some
modifications in the purification processes which could lead to the biosimilar, and that might not
be similar to the innovator product. It implies that even though the protein molecules units would
be similar, safety issues might take place because of the differences in the 3d structures and
folding (Christodoulou, 2014).
On the other hand, the major weakness is that all of the products that are manufactured
through biotechnology have the potential due to which they could bring immune reaction using
antibodies production. According to Tukdeo (2016), the antibodies that are created might start an
immune response to the endogenous as well as therapeutic protein that could be threatening to
life. In addition to this, for preclinical studies, the biosimilars immunogenicity become complex
to be predicted as being a biological response. Hence, this makes it very significant carrying out
the studies of clinical immunogenicity before they are approved, and this is again not possible.
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Another weakness is related to the funding of biosimilars. It has been argued that
biosimilars require large amounts of funding (Christodoulou, 2014). This is because challenging
guidelines have been introduced for biosimilars in various countries which deal with its
production. Hence, investors who want to enter this market may require huge funding to start it.
In addition to this, there has been a lack or shortage of credibility with regards to the community
that prescribe biosimilar drugs (Tukdeo, 2016). In Europe, the primary biosimilars have achieved
approval in 2006 and controls for biosimilars in the US are still undetermined. Generally, for
western markets which are highly regulated, clinical experience of a biosimilar is restricted to
several years. This extremely constrained experience is a complexity to the long-term
understanding of the particular originator drugs. The decision of prescription without
programmed substitution mechanism, and additionally the buying choice, is well on the way to
be taken by the treating medicinal doctor (Pan, Potumarthi, Sundari and Danquah, 2011).
Since the biosimilar cannot emphatically separate itself on safety and efficacy, the
argument of a worthwhile cost - on which the prescriber does not earn money — would not
repay the detrimental lack of clinical experience of the biosimilar. Along these lines, the
medicinal services group applies a solid doubt to biosimilars. However, it is believed that this
scepticism could be overcome. Most of the biosimilar companies are already persuaded that
trustworthiness in the prescribing community would not be achieved by what they stated;
however, it would be achieved through their activities and actions that could deliver the wide-
ranging market for a product. On the other hand, there are various regulations for the
development of drugs normally offer room for organisations for the interpretation (Pan,
Potumarthi, Sundari and Danquah, 2011). In a nutshell, new entrants can go about more easily,
or they could experiment themselves with the help of taking a rough drive. Hence, it is believed

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that the harder specifications are set in order to achieve biosimilars, the more credibility
companies could build in for their products while having more potential for selling it. In a phase
of the development of biosimilar, if the company would go an extra mile, it is believed that extra
money and time that is spent would effectively save in post-approval of marketing expenses. It is
prudent to get the interest of the prescribing community at an early stage and to maintain this
interest by soliciting them to share their view from a perfect product offering. These perspectives
ought to then be incorporated into the target profile of product (Pan, Potumarthi, Sundari and
Danquah, 2011). In spite of the fact that there is just restricted space for difference of a
biosimilar, this constrained space ought to be involved in building up a product offering that is
more focused on the prescriber's and the patient's needs contrasted and the originator.
On the other hand, after a lot of financial assets are spent with regards to the approval as
well as a development of biosimilars, conquering the credibility hurdle when entering the market
adds up to another generous investment. For a small organisation, this may be excessively
troublesome, making it impossible to tolerate. Hence, it is expected to perceive the different sorts
of partnering activities among larger and small development oriented organisations working in
pharmaceuticals. However, the last being in charge of market access for the product and giving
believability through its set up product offerings and brands.
In addition to this, other weakness is related to the absence of credibility pertaining to the
forming community for policies. The European Medicines Agency (EMA) requires broad
nonclinical and clinical similarity data between the biosimilars and the originator and
compatibility and immunogenicity appraisals after repeated utilisation. In any case, automatic
substitution at the desk of a dispenser is still not a market reality. So far, the clinical involvement
with biosimilars is considered as constrained as it is today, the application of automatic
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substitution by the policy shaping the prescribing group would not happen (Mota, 2014). The
nonappearance of automatic substitution has two impacts for the market of biosimilar: to start
with; it is a self-satisfying contention as it permits the originator business to keep alive their
myth of non-similarity of biosimilars: second, it makes another obstacle for the market
infiltration of biosimilars (Mota, 2014).
Another weakness for the biosimilar industry is related to the absence of credibility of
biosimilars as an industry. The biosimilars business is a developing industry that has not yet
demonstrated its long-term suitability. In this manner, the supply side of the biosimilars market
still has far to go in order to persuade the demand side and the controller that it is a significant
partner. This absence of industry credibility likewise weakens the quality of the biosimilars
business in its communications with these market partners. The more managed a market and its
industry, the more critical campaigning by the partners develops with a specific end goal to
impact strategy setting to support them (Boikov and Mebius, 2014). The industry of biosimilars
has a distinctive interest for the development of more credibility since this will permit it to
impact further approach results adjusted to its interests.
Opportunities
There have been many opportunities for growth in biosimilar markets more specifically
for new entrants who have been planning to enter into this market. One of the opportunities is
related to the reimbursement policy as well as favourable pricing structures. According to
Boikov and Mebius (2014), in highly regulated and thus costly (additionally fiscally attractive)
markets, healthcare services customers apply constantly mounting pressures on the life sciences
industry to deliver treatments at a lower cost to the patient. As biosimilars are biotechnology-
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determined medications and in this way considerably more expensive to create and deliver than
small molecule artificially manufactured generics, a difference in price in the smaller two-digit
rate range will, at any rate, add up to significant cost saving per treatment contrasted with the
originator (Boikov and Mebius, 2014). In those types of markets where there are fewer
regulations, and where the buyer base will have even less purchasing power, the evaluating
contention for biosimilars might be significantly more appealing.
On the other hand, another opportunity for growth in biosimilar market is that the
introduction of biosimilars has driven the growth for increased innovation and development in
the market. A biosimilar should be equal to the originator fundamentally in its safety profile as
well as efficacy with a specific end goal to acquire approval from authority; such correspondence
should be demonstrated clearly. Despite that, it might prove to be difficult to offer a very similar
product to the prescriber with a specific end goal to display a convincing case; the biosimilars
should be decidedly separated from its originator (Boikov and Mebius, 2014).
The main positive differentiator will certainly be estimating, however, once a second
biosimilar enters the market, rivalry on price alone will disintegrate profit margins for all supply
side members, in the long run to a non-sustainable completion. Therefore, it is in the interest of
the biosimilar business to decidedly separate their products in extra ways (Zhang et al. 2015).
This may play out as an effective development driver since organisations will search for
differentiations in innovations, for example, streamlined inventions, delivery modes, variants in
packaging, size and service parts of their product offering.
Another major opportunity for biosimilar market is related to the growth of the non-
saturated and immature markets. As a result, policies related to reimbursement and pricing tends
to offer a significant opportunity for growth in the market for biosimilars specifically with

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regards to those markets which are saturated as well as mature. Despite that, it might likewise be
intriguing for the biosimilars business to look to the less directed, developing and non-saturated
pharma markets of rising economies. The change there will be dissimilar (Zhang et al. 2015).
While those markets which are highly regulated markets of western economies are pressed, the
business sectors in rising economies are developing. Their emerging working classes gain decent
salaries giving them sound purchasing power, and they need to spend their cash on best in class
commodities and services, including therapeutic services and supplies. These developing white
collar classes as a new and developing customer base will soon be more than the consumer base
of western economies (Zhang et al. 2015).
Threats
Apart from the strengths, weaknesses and opportunities for the biosimilar market, there
have been many threats in the industry. One of the major threats is related to the changing
regulatory environment which is against the interest of the industry. This threat relates to the
absence of validity in the policy forming community and also the absence of credibility as an
industry. On the other hand, regulatory powers tend to outline regulations considering the
influences of different partners and based upon different policy objectives (An, 2011). As
depicted above, the absence of long-term clinical experience and also the absence of
demonstrated long-term practicality as an industry debilitates the remain of the biosimilars
business when attempting to impact policy setting process in its support (AbiRaad and Smith,
2015; Jing et al. 2012). A small organisation might not have the impact to affect the policy
setting process, yet in an indirect way: for instance through industry relationships. On the other
hand, some organisations ought to take an interest in this procedure. Likewise, some
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organisations can and should explore the advancing regulatory environment. A constant
discussion with the concerned authorities started ahead of schedule in the improvement of a
biosimilar will particularly help to effectively characterise targets and build up the product to the
expectations of authorities (AbiRaad and Smith, 2015).
In addition to this, there are also extremely strong instruments accessible for some
organisations, for example, the SME-Status from the EMA, which then opens doors for casual
relations with authority. Another major threat to the biosimilar market is related to the shifts and
improvements in technology. A biosimilar is intended to be similar, neither sub standard nor
prevalent to the reference product. When technology enhances to yield better products (e.g..
biobetters) or the business embraces another best quality level treatment for a particular
condition, it will be troublesome for the biosimilars that depend on a past innovation era to resist
(Faria, 2015). The argument for pricing related to biosimilars and finally its other arguments for
differentiation will just insignificantly close the gap; however, the gap itself will remain. Within
the presence of such a circumstance, there is a visible need to consider techniques for enhancing
risk. Concerning vulnerable product, it might be worth considering marketing the medication
into lower edge markets in light of the fact that these may not yet be prepared to finance the most
recent change in technology.
On the other hand, another threat to the biosimilar industry is related to the domain of
intellectual property. The originator industry with its longstanding background in securing its
developments tries to keep biosimilars rivalry out of the market through extensive strategies of
intellectual property. Ultimately the centre of medication, its molecule, may fail patent, yet this
does not imply that biosimilar producers are then free to struggle. Faria (2015) also stated that
originators construct cautious IP walls around each part of the molecule. The principal wall after
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molecule protection is related to the up and down stream handling. The following wall
encompasses the formulation and afterwards come security efforts around basic analytical
techniques (Laskowska, n.d). The latest wall, which is just applicable to some authorities, would
be around the assigned utilisation of a drug. For smaller organisations which are less stable
financially, the possibility of a long, risky and expensive patent prosecution lawsuit may
demonstrate too substantial a burden to convey (Faria, 2015). Before starting the development of
a biosimilar, a smaller organisation ought to put resources well into FTO analysis. Lawyers
might be costly; however, patent lawyers are certainly defensible regardless of their rate and may
save the small biosimilar producer wealth. Unique consideration must be paid to the various
levels of security that the originator is working around a molecule. Hence, such investigation for
FTO also required a concise planning in the phase of the development as well as its supply chain
which would serve as an obligation to assist the lawyer in evaluating the various risks which are
related to IP throughout the processing stages of the product (Laskowska, n.d).
Hypotheses
With regards to the hypotheses developed for this study, it has been found through
surveys and qualitative research that the key factors behind the introduction of biosimilars in the
pharmaceutical market included pricing and biosimilarity. With regards to pricing, the cost of
biosimilars is less when compared to originator drugs. This conception was also found in the
SWOT analysis where strengths of biosimilars are related to its lower costs which differentiate it
from other originator drugs. On the other hand, the biosimilars are also identical to originator
drugs. Another hypothesis was related to that the biosimilars competition with originator will be
different from the one of the generics. This hypothesis was also proved to be true as there are

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future predictions related to biosimilars that it will have tough competition with originator drugs
and will more likely emerge as a growing industry because of several reasons discussed in the
analysis. In addition to this, another hypothesis discussed that the penetration of biosimilars in
emerging market would prove to be a major challenge for key stakeholders. This is because a
majority of the emerging markets have kept lower hindrances for clinical trial requirements and
also administrative control as compared to developed countries such as the EU and US.
However, some of the operational factors that included regulatory requirements and clinical trials
might be problematic for sponsors for biosimilars.
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CHAPTER 4 - CONCLUSION
With millions of individuals and an enormously neglected therapeutic need, uptake of
quality biosimilars is anticipated to be significant. These business sectors, however, are not so
effectively reached by the Western multinational pharmaceutical organisations. The obvious
elevated quality of major countries in emerging markets has prompted to a progression of steps
being taken by their regulatory authorities regarding foreign organisations. In addition to this,
foreign infrastructure, as well as local favouritism and production investments, is now becoming
a common prerequisite in a majority of the developing countries. Thus, opening the possibilities
of biosimilars will require a focused methodology along the entire value chain, from enhancing
the clinical development program through building up the most reasonable technique for
commercialization. What is required is to adjust trade-offs between in-house investments
opposite strategic alliances together for the accomplishment of cost-effective outputs. Time-to-
market would likewise be minimised; additionally tailoring of the topography would help cope
up to heterogeneous landscapes. Hence, the entry of biosimilars in the pharmaceutical industry of
emerging markets would be strongly governed by the major companies in addition to strong local
players.
The experiences of emerging markets with biosimilars have been constrained, which
implies they hold tremendous possibilities in the years to come. Despite that, various boundaries
would come in the way for its prosperity. While improvement of biosimilars is shifted crosswise
over regions, they will presumably take diverse ways in their process of development.
Organisations hoping to exploit the biosimilars opportunity should be clear of their
strategic importance within the industry, as far as portfolio fit, financial suitability and
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cooperative energies inside the value chain, remember this might be a built up or developing
markets' performance. Hence, an overall understanding of the financial upsides and risks of the
venture will be basic, given realistic situations of the size of the potential, the treatment ranges
where it will be found, and whether the joint effort and cooperation are required to get to strategy
will be imperative for effective entry. In particular, organisations ought to be committed over the
long term. Regardless of immense prospects, biosimilars may take quite some time to be known
as an example of a success story.
In conclusion, treating the individual meets the commitment of saving the self-sufficiency
of a patient by perceiving that biosimilars increased access to required biologic treatments to
those people who have been generally and financially not restrained. It is plainly obvious that a
thoughtfully as well as an emphatically planned development program for a biosimilar guarantee
that the most good is accomplished while potential harm or risk is minimised, saving the
standards of helpfulness and nonmaleficence. The majority of this guarantees the principles of a
fair system of health care allocation which are met by permitting equivalent access to important,
and now available, life-protecting bio therapeutics as biosimilars. In a nutshell, developing
markets and biosimilars can be the model of a genuine cooperation between governments,
research sponsors, the biotechnology business, and the unavoidable patient. Ethically, it is basic
that one should accomplish this balance of safety, viability, innovation, as well as access.
Recommendations
The development and maintenance of an early-stage biotech organisation require a plan
of action that streamlines financing, marketing, and operational systems. Contingent upon the

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accessibility of seed capital and financing alternatives, the organisation may embrace 1 of 3
plans of action on which strategic and tactical plans can be executed by the organisation:
The company can build or develop the biosimilar product in-house from the phase of
bench research to approval in the market.
The company can license as well as secure key organisations together, associations, and
licensing deals
Finally, the company can sell, divest, joint venture or other alliances, divestiture, or exit
strategies.
The practical way forward for endorsement of biosimilar products in emerging countries
would need to be unique to the country’s setting while staying attached to scientific basics and
remembering the needs and limitations of the nation. The extensive part of biosimilars which
will be introduced in developing nations would be products whose licenses have terminated and
where the original innovator product may not be permitted in the country (Patel, Shah and Patel,
2014). It is additionally conceivable that no patent exists in emerging economies for a few
products and hence, originator and similar exist together. For all products, the subject of
accessible reference standards and profiles would continue to last. The next entry of biologics of
business interest to the market will turn into a flaming issue where the controller cannot hope to
wait to perceive how the enactment is created in the US or somewhere else before making a
move.
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Appendix
ONLINE SURVEY
Thank you in advance for your help with this!
Please email if you have any questions
Ryma Batel
Msc Regulatory Sciences
University of the Western Cape in partnership with Hibernia College, Ireland
Email: batel.ryma@gmail.com
Part 1: General background information
Q1/Which department /sector do you work for?
Regulatory Affairs
Quality Assurance
Clinical Trials
Doctor
Pharmacist
Q2/How do you qualify the Region you work in ?
Developed
Developing
Q3/Do you work in biotech company?
YES
NO
Part2 :Biosimilars Knowledge
Q1/ Are you familiar with biosimilars?
YES
NO
Q2/Is biosimilars same as generics
Yes
NO
Not Sure
Q3/Do you think it is appropriate for a pharmacist dispensing a biosimilar in place of an
originator medicine (or vice versa) without consulting the prescriber?
YES
NO
NOT SURE
Q4/please would you rate your concern about the safety and efficacy of biosimilars from 0 to 10?
Answer:
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72
Part3 biosimilar growth
Q1/ Which regions and countries present the greatest potential for the biosimilars business?
The Triad
BRIC
MENA
Other-please Specify....
Why?
Q2/ Does your company planning more capital investment this year than last year?
Yes
No
Q3/Do you think that Biosimilars could be a key growth driver of your firm over the next 5
years?
Yes
No
Not sure
1 out of 72
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