Four new FDA guidances and proposed rule advance biosimilars policy framework

Today, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  The guidances include a final guidance and a draft Q&A on the “Deemed to be a License” provision of the BPCI Act; as well as a new and revised draft Q&A on biosimilar development as it relates to the BPCI Act, which contains finalized guidance in Revision 1, and draft guidance in Revision 2.

One important nugget in these documents is that FDA apparently hasn’t moved significantly from its restrictive view of how exclusivity will be applied to the “deemed licensed” products.  Another is that FDA Commissioner Dr. Scott Gottlieb’s statement makes clear the agency’s desire to more quickly bring biosimilars to market.

Stay tuned for expanded analyses of these reference documents.  Listed below are the full titles with links to each.

  • Definition of the Term “Biological Product” (proposed rule)
  • Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (final guidance)
  • The “Deemed to be a License” Provision of the BPCI Act; Questions and Answers; Guidance for Industry (draft Q&A)
  • Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry (Revision 1)
  • New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2); Guidance for Industry; Draft Guidance


Authored by Philip Katz, Gary L. Veron and George O'Brien


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