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FDA Releases Long-Awaited Draft Guidelines on Biosimilars

  • 02.10.12
  • Paul A. Calvo & Timothy J. Shea, Jr.
  • Sterne, Kessler, Goldstein & Fox

On February 9th, the U.S. Food and Drug Administration issued the Agency's first set of draft guidance documents outlining the framework for how it will evaluate applications for regulatory approval of biosimilar products.  The long-awaited guidances provide the first detailed comments from FDA on the topic.  The Biologics Price Competition and Innovation Act of 2009 ("BPCI Act) established an abbreviated approval process in the U.S. for obtaining licensure of a biological product considered to be biosimilar to a previously approved biological product ("reference product").  Although the BPCI Act was enacted on March 23, 2010, until Thursday FDA had not provided any formal guidance to the biopharmaceutical industry as to how the agency would implement the statutory provisions.

The three "Guidance for Industry" documents released by FDA are:

  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • Quality Considerations in Demonstrating Biosimilarity to a Reference Product
  • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

The draft guidances represent the "current thinking" of FDA on biosimilar product approval, but do not establish any legally enforceable responsibilities on the Agency or biosimilar sponsors.  They are to be viewed only as recommendations, except where specific regulatory or statutory requirements are cited.  The FDA has established a 60-day period in which public comment on the draft guidances will be accepted.

For highlights of the guidance documents, download the PDF.

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