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.