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Comment & Response
September 26, 2017

Challenges to Biosimilar Substitution—Reply

Author Affiliations
  • 1Yale University School of Medicine, New Haven, Connecticut
JAMA. 2017;318(12):1186-1187. doi:10.1001/jama.2017.11937

In Reply We agree with the concern that an ambiguous and convoluted patent dispute resolution process could unnecessarily delay market entry of biosimilars, thereby limiting price competition and reducing biosimilar cost savings. This potential obstacle applies to all biosimilars, whether they treat acute or chronic conditions.

Like the Hatch-Waxman Act, the BPCIA was legislatively negotiated to strike a balance between 2 potentially competing policy interests—maintaining incentives to develop innovative biologic products and processes and facilitating efficient transition to a market with lower-cost copies of those products at the conclusion of a patent term.1 The implementation of the BPCIA is still in its infancy, and the process of resolving difficult and hotly contested issues of statutory interpretation is continuing. One federal circuit judge described the BPCIA as a “riddle wrapped in a mystery inside an enigma.”2 Importantly, however, a recent ruling by the US Supreme Court has clarified portions of the BPCIA, holding that a federal injunction is not available to compel biosimilar makers to disclose their FDA biosimilar applications to rivals, and also that biosimilar makers do not have to wait for FDA approval of the biosimilar before providing 180-day notice of commercial marketing. This decision may amplify the appeal of the biosimilar approval pathway for manufacturers.3

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