Tuesday, March 8, 2011

Vol. 1, No. 5: Will the Biosimilars Act Encourage Manufacturers to Bring Biosimilars to Market?

Will the Biosimilars Act Encourage Manufacturers to Bring Biosimilars to Market?
Joanna T. Brougher, Of Counsel, Boylan, Brown, Vidgor & Willson LLP and Adjunct Lecturer, Harvard School of Public Health
David A. Fazzolare, Intellectual Property Attorney, Morse, Barnes-Brown & Pendleton, PC and Candidate for M.S. in Biotechnology with a concentration in Regulatory Affairs, Johns Hopkins University

Brougher and Fazzolare explain that the Biosimilars Price Competition and Innovation Act, enacted in 2010, “may fail to provide a clear pathway to market-approval.” They express concern that manufacturers will not produce biosimilar products, since the patent process allows a biosimilar only a limited period of market exclusivity that may not be worth the cost of development.

The authors specifically recommend that FDA:
  • Award market exclusivity to first-to-market biosimilars and strengthen market exclusivity for interchangeable biosimilars.
  • Clarify generic market exclusivity timelines to strengthen interchangeable biosimilar market exclusivity.
  • Eliminate ambiguities permitting collusive agreements between brand and biosimilar manufacturers that may harm generic competition.
This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

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