Biosimilars' Growth in Pharmerging Markets: Regulatory Analysis

This report, prepared by Ryma Batel from the University of the Western Cape in collaboration with Hibernia College, analyzes the growth of biosimilars in pharmerging markets. It begins with an introduction, background, problem statement, research aims and objectives, research questions, and hypotheses. The literature review explores the market position of biosimilars, contrasting emerging markets with established players, and examining growth drivers, opportunities, and challenges. The analysis includes findings from an online survey and a SWOT analysis to assess strengths, weaknesses, opportunities, and threats. The report also discusses the regulatory environment, challenges for stakeholders, and strategies for improving biosimilar regulation and patient access. Recommendations and references are provided to conclude the study.

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.