Roosevelt Institute | Cornell University

Biosimilars: The Future for the United States Pharmaceutical Industry

By Holly GracePublished October 27, 2016

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Biosimilars are biologic medicines that are produced in living cells through multi-step processes. Unlike generic drugs, which are made through chemical synthesis, the environment biosimilars are created in impacts them. With numerous leading prescription drugs losing their patents in the next few years, pharmaceutical companies are eagerly seeking ways to provide new products that are difficult to replicate and biosimilars seem to be the solution.
The first biosimilar drug in the United States, Zarxio, became available a year ago, and many more drugs like it are on their way. Many people have never heard of biosimilar drugs, but these drugs have the potential to dramatically change the pharmaceutical industry. What is a biosimilar drug? Biosimilars are biologic medicines that are produced in living cells through multi-step processes. Unlike generic drugs, which are made through chemical synthesis, the environment biosimilars are created in impacts them. Like how no living organism is identical to another and their environment impacts them, biosimilar molecules are also unique and impacted by their surroundings. Each molecule is also hundreds of times larger than generic drug molecules, making them more difficult to copy by competing pharmaceutical companies.

The variation between biosimilars and the inability to manufacture exactly the same product each time creates many concerns for regulation and FDA approval. This problem has been one of the major reasons this type of drug has only recently become available in the United States. The biosimilar must be classified by the FDA as "interchangeable" with the FDA-approved reference product and meet the Agency's safety and efficacy standards. The Biologics Price Competition and Innovation Act as well as the Patient Protection and Affordable Care Act amended this definition in 2010 to shorten the pathway to licensing the biological products, and this has largely contributed to the ability of biosimilars to be available in the United States.

This new type of drug will benefit not only pharmaceutical companies as many of the most profitable drugs lose their patents in the next few years but also patients as the number of available treatments will increase. This is especially important at this time, as a large percentage of United States medical expenses are due to the growing number of elderly people in the baby boomer era and people continue to live more into old age, so there are more patients with chronic diseases to treat. Zarxio, produced by Sandoz, claims to be a more affordable form of biologic drug for cancer treatment than previous products that have large co-pays for patients. Pharmaceutical companies with biosimilar products will need to pay more to reach the approval stage in the FDA but these products will be much more difficult to copy and make generic drugs from. Biosimilars have been compared to snowflakes, with very large, complex, and sensitive structures.

The United States saw its first biosimilar drug enter the market and is anticipating many more in the near future. With numerous leading prescription drugs losing their patents in the next few years, pharmaceutical companies are eagerly seeking ways to provide new products that are difficult to replicate as generic brands and biosimilars seem to be the solution.