The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act signed into law by President Obama on March 23, 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product. The first application for licensure through the abbreviated pathway was received by FDA in 2014 and the development, review, and manufacture of biosimilar products has become an important part of the biotech landscape. While the risk based, patient centered principles of practice for licensure of biosimilars have remained stable since the initiation of these programs, some specific areas of technical focus and scientific consideration have arisen which could inform and aid the timely provision of high quality medicines through the abbreviated pathway. This talk will review the foundational elements of the program and offer a discussion of learning points and opportunities for enhanced development of biosimilar products and related processes.

Considerations in the development and control of biosimilar manufacturing in the United States

251st National Meeting (2016)

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