By: David A. Fazzolare
The Biologics Price Competition and Innovation Act of 2009 (the “Biosimilars Act”) was enacted in 2010 as part of the Patient Protection and Affordable Care Act. The Biosimilars Act gives biosimilar manufacturers an abbreviated market approval pathway akin to the abbreviated approval pathway for generic drugs under the Hatch-Waxman Act.
I recently coauthored an article about the Biosimilars Act entitled “Will the Biosimilars Act Encourage Manufacturers to Bring Biosimilars to Market?” The article was published in the Food and Drug Law Institute’s (FDLI’s) Policy Forum and is available for download here. A brief summary of the article follows.
Like the originally enacted Hatch-Waxman Act, the Biosimilars Act raises issues that must be addressed to strike the appropriate balance between promoting innovation and increasing access to more affordable medicines. These issues include: (1) inadequate incentives to encourage development of biosimilars; (2) uncertain exclusivity timelines for biosimilars that may weaken biosimilar market exclusivity; and (3) ambiguities that allow brand and generic biologics manufacturers to extend their market exclusivity and delay authentic biosimilar competition.
We proposed the following solutions to address these issues: (1) award market exclusivity to first-to-market biosimilar products and strengthen market exclusivity for first approved interchangeable biosimilars: (2) clarify the uncertain generic exclusivity timelines that diminish the value of interchangeable biosimilar market exclusivity; and (3) amend the Biosimilars Act to remove ambiguities that encourage agreements between brand and generic biologic manufacturers that delay authentic biosimilar competition.
Adopting these solutions could strengthen incentives to encourage increased biosimilar development without undermining existing incentives for developing innovative biologics.
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