• FDA Publishes Three New Draft Guidance Documents on Biosimilar Product Development
  • March 7, 2012 | Authors: Azim Chowdhury; Frederick A. Stearns
  • Law Firm: Keller and Heckman LLP - Washington Office
  • On February 9, 2012, the U.S. Food and Drug Administration (FDA) released a set of three draft guidance documents as one of the first major steps in the Agency's implementation of the abbreviated approval pathway for "biosimilar" biological products created by the Biologics Price Competition Act of 2009 (the "BPCA"). The BPCA was enacted as part of Section 351 of the Patient Protection and Affordable Care Act of 2010. FDA is accepting comments on these draft guidance documents, each of which is discussed in detail below, until April 16, 2012. FDA is also holding a public hearing on May 11, 2012 to receive feedback from interested parties on the draft guidances.