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FDA Releases Guidelines for 12-Year Period of Reference Product Exclusivity for Section 351(a) Biologics

  • 08.14.14
  • Timothy J. Shea, Jr.
  • Sterne, Kessler, Goldstein & Fox

The U.S. Food and Drug Administration has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009, which established an abbreviated approval pathway in the U.S. for biosimilar versions of previously approved therapeutic biologics. The proposed guidance, which was released on August 8, 2014, addresses the 12-year period of reference product exclusivity granted under section 351(k)(7) of the Public Health Service Act.

Read our full analysis of the proposed guidance by downloading the attached PDF.

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