The Food and Drug Administration recently held a public hearing to obtain input on issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009. Among those providing testimony at the two-day hearing were pioneer drug companies, potential biosimilar manufacturers, trade groups, patient advocacy organizations, and physicians who treat patients with biologics. The FDA sought and received comments on:

  • scientific and technical factors related to a determination of biosimilarity or interchangeability;
  • the type of information that may be used to support a determination of biosimilarity or interchangeability;
  • development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products;
  • scope of the revised definition of a “biological product;”
  • priorities for guidance development by the FDA;
  • scientific and technical factors related to reference product exclusivity;
  • scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCIA; and
  • the establishment of a user fee program for biosimilar and interchangeable biological products.

The discussions at the hearing highlight the amount of work that still needs to be done to implement a biosimilars review pathway in the United States. A live webcast and recording of the hearing is viewable at https://collaboration.fda.gov/p48258466/ and https://collaboration.fda.gov/p68871994/. The FDA will also accept electronic and written comments until December 31, 2010.