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Biologics & Biosimilars

What are Biologics and Biosimilars?

Biologics or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics include a wide variety of products such as gene and cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines. Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.

A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA).

Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity or potency in one or more uses for which the reference product is licensed and the biosimilar seeks licensure.



Increasing Competition Among Biologics and Biosimilars

In 2010, Congress approved the Biologics Price Competition and Innovation Act (BPCIA), creating an abbreviated approval pathway for biosimilars, while maintaining incentives for continued medical advances. To support innovation and competition in the marketplace, Congress provided 12 years of data protection for innovative biologic medicines. This framework provides a balance between providing incentives for development of innovator biologics and spurring the introduction of and access to biosimilars. To date, the FDA has issued several draft and final guidance documents to assist biosimilar sponsors in generating data to support biosimilar applications. FDA guidance and regulations provide insight into the agency’s current thinking regarding how it will evaluate biosimilar biological products. The FDA approved the first biosimilar product for marketing in the United States in March 2015. The FDA is working to provide additional guidance on how biosimilar products could be designated “interchangeable” to reference products. In 2018, FDA Commissioner Gottlieb introduced the Biosimilars Action Plan to help spur competition and innovation for biosimilars. As of October 2019, 23 biosimilars have been approved in the U.S.1

As the market and experience with biosimilars increases, we expect usage to play an expanded role in options for patients and decrease prescription drug spending. PhRMA commends the FDA for its efforts to enhance competition and encourage innovation in the biologics market and looks forward to continuing to work with the FDA on science-based regulations that ensure patient safety.