Biosimilars in the United States: Implementation Challenges and Lessons Learned from the European Union

The Patient Protection and Affordable Care Act established a legal framework for an abbreviated approval pathway for off-brand versions of biotech drugs, known in the United States as biosimilars, and charged the Food and Drug Administration (FDA) with the authority to implement the biosimilars pathway. Following the FDA’s recent public hearing on biosimilars, many questions remain unanswered: What are the key implementation issues associated with biosimilar entry in the United States? And what should government’s role be in regulating the process?

On Wednesday, December 1, Brookings hosted a discussion on these key issues and experiences as the FDA considers an approach to implementing a U.S. biosimilars pathway. Moderated by Brookings Vice President and Director of Governance Studies Darrell West, a panel of experts addressed regulatory and implementation challenges and opportunities and provide a comparative analysis of the European Union’s experience in creating a biosimilars approval pathway. The European Union, as well as several countries around the globe, has already implemented an approval pathway for biosimilars.