Biotechnology and the Cost of Biological Drugs in the United States

This article discusses the high cost of biological drugs in the United States and the potential for biosimilars to reduce costs. It includes perspectives from FDA administrators, insurance plan administrators, and politicians, as well as the benefits and challenges of biosimilars.

Running head: BIOTECHNOLOGY 1
Biotechnology
Author
Institution

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Biotechnology
Introduction
In 2010, Congress approved the biologics price competition and innovation act (BPCIA)
that created an approved abbreviated pathway for biosimilars. They did this while maintaining
incentives for the continued medical advance. So that there can be balance within the increased
competition among biosimilar and biologic products, there is the need for the motivations to
support future innovation in the medical field. Thus, Congress gave the biopharmaceutical
innovator with 12 years for the protection of data for the biologics medicine.

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Table of content
Patient currently spending $20,000 per year for a single recombinant product………………..4-5
FDA administrator………………………………………………………………………………4-5
Spokesperson for Generic Pharmaceutical Association………………………………………...5-6
Vice president for marketing for company manufacturing and innovator recombinant
product………………………………………………………………………………………….5-6
Plan administrator for an insurance company…………………………………………………..6-7
Politicians running for national office…………………………………………………………..6-7
Conclusion……………………………………………………………………………….……...7-8
References………………………………………………………………………………………8-9

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Patient currently spending $20,000 per year for a single recombinant product
The cost of the biological drugs in the United States is jacking. There are no signs of
these costs lowering. This creates a huge burden for citizens who rely on biological drugs to
maintain their health condition. Patients currently spending $20,000 per year for a single
recombinant medication are far from bearable. Although biological drugs are more effective
compared to biogeneric drugs, many patients will opt to use them. This is with the fact that they
compromise their health and significantly suffer in the process. The patients would hesitate to
drop the use of biological drugs due to their effectiveness compared to biogeneric drugs. Due to
this patient keeps hoping that the price of the biosimilar that is imperatively effective would not
hike. This is because the burden of the drugs is too much on the patients who rely on medication
for sustaining their health.
FDA administrator
Biogenerics have the potential of reducing the cost of treatment. Meanwhile, regardless
of its ability to reduce cost, there are still doubts about the effectiveness. Thus, they have fears if
they switch to biogenerics, they will get the same results of biological drugs. Authorized by the
patient protection and affordable act 2010, Food and Drug Administration (FDA) created a new
regulatory approval for biosimilar which is almost the same of the biological drugs in terms of
safety, potency, and efficacy, although they are manufactured by different companies (Herper,
2014). They must also have the same to biological drugs in term of the dosage form, strength,
mechanism action and the route of administration. Meanwhile, there was three marketed
biogeneric and two more approved but are not yet marketed. Thus, they make sure that the

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manufacture of the generic drug is similar to the biologic drugs in terms of biological and
chemical composition.
Spokesperson for Generic Pharmaceutical Association
The spokesman of the generic pharmaceutical association unveiled a new national effort
to contain the cost of the medical prescription. The association is changing to the association of
the Accessible medicines. They launched "keeping medicine in reach" that narrates the story of
the patients whose lives and health improved by the access of generic medicines. This is with the
consideration of the association drive which is access to quality, safe and effective medicine
(Orelli, 2016). The association new identity will enhance recognition that the biosimilar and
generic medicines industry and thus lowering the cost of medicine due to increased competition
with biological drugs.
Vice president for marketing for company manufacturing and innovator recombinant
product
The new innovation in the company manufacturing innovator recombinant products will
have a significant impact in reducing the cost of medicine for the patients. The vice president of
these company stated of the several biopharmaceuticals, including insulin analogs and analog
provides an opportunity for companies to attempt to manufacture copies usually referred to a
biosimilar. Reassured that the copy is equally effective and safe as it is essential to have
conventional products. However, the biopharmaceuticals created from living organisms and
manufactured through complex process contrast in many aspects from biological drugs. The
manufacturing of biopharmaceuticals is a sophisticated and multistep process that comprises
culturing the cells that are derived from the expression system (Orelli, 2016). In March 2010, as

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part of the US reform bill food and drug administration endorsed legal authority through the
biologics price competition and Innovation act of approving biosimilar and interchangeability
authorize biosimilar with their innovator biologic. The amendment of biologics price competition
and innovation act outlines an abbreviated approval pathway that was created the biological
products that were similar and interchangeable with FDA licensed innovator product (Rifkin &
Robert, 2018).
Plan administrator for an insurance company
Specialty biologics are currently the biggest drivers of pharmaceutical cost growth. In the
United States, nine patents for the top 20 selling biologics are supposed to expire by the year
2020. However, in terms of ensuring the biosimilars drug the insurance companies have hesitated
in ensuring the biosimilar drugs. However, recently due to safety created by the FDA, most
ensuring companies have incorporated the biosimilar drugs. This is a boost to patients who have
to rely on the biosimilar drugs for their medication.
Politicians running for national office
The biogeneric and biosimilar companies have hardships entering in the market. This is
due to biological manufacturing companies using patent lawsuits to keep biosimilars from
entering the market (Cahill, 2013). Moreover, the influence of the politicians running in national
office cooperating with the biological drugs companies to prevent biosimilar introduction to the
market. This is because the introduction of the biosimilar drug in the market will result in the
competition and significantly cut their profit. Thus, they apply business tactics to keep down the
competition down while raising their prices. Thus, these will significantly lead to patients having
hardships in accessing medicine and thus paying more than $20,000 for medication.

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Conclusion
It is essential to point out that biologics are more effective than biosimilars. Meanwhile,
despite this, it is my advice for the patient to consider taking biosimilars. This is in disregard
lacking the same measure as the biologics. The standards set by the FDA of ensuring the
biosimilars are safe and effective are therapeutically equivalent to biologics. Moreover, because
the prices of biosimilars are lower than those of biologics and hence I would advise the patients
to consider taking them.

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References
Cahill, J. (2013). AbbVie takes on Walgreen in fight to limit generic biotech drugs. Retrieved
from: https://www.chicagobusiness.com/article/20131016/BLOGS10/131019881/
walgreen-hospira-battle-abbvie-over-state-laws-on-generic-biotech-drugs
Herper, M. (2014). What Will Happen When Biotech Drugs Go Generic? Retrieved from:
https://www.forbes.com/sites/matthewherper/2014/06/13/what-will-happen-when-
biotech-drugs-go-generic/#7beb50617a00
Orelli, B. (2016). 9 Things You Need to Know About Biosimilar Drugs. Retrieved from:
https://www.fool.com/investing/general/2016/03/28/9-things-you-need-to-know-about-
biosimilar-drugs.aspx
Ossola, A. (2016). What Is A Biosimilar Drug? Retrieved from: https://www.popsci.com/what-
is-biosimilar
Rifkin, M, D & Robert, M. (2018). A Perfect Storm Brews for Biosimilar Marketing. Retrieved
from: https://www.onclive.com/publications/oncology-live/2018/vol-19-no-18/a-perfect-
storm-brews-for-biosimilar-marketing