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.
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