Biosimilar Product Approval and the Implications of Sandoz v Amgen

07/31/2017

The U.S. Supreme Court’s much-awaited decision in Sandoz Inc. v. Amgen Inc., 2017 BL 198127, U.S., No. 15-1039, 6/12/17 is favorable to biosimilar applicants on two key sections of biosimilars law but many questions remain that will need to be addressed through litigation or regulation under this complex new regulatory regime.

On June 12, 2017, in a unanimous decision authored by Justice Clarence Thomas, the Court addressed two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (‘‘BPCIA’’ or ‘‘Biosimilars Act’’). Specifically, the Court considered: (1) whether a federal injunction is available to enforce the BPCIA provision that a biosimilar applicant (‘‘applicant,’’ i.e., a company seeking approval to market a biosimilar) engage in the ‘‘patent dance’’ by providing the reference product sponsor (‘‘sponsor,’’ i.e., the company that markets the original biologic drug) a copy of its biologics license application and certain related manufacturing information, and (2) whether the BPCIA’s 180 days’ premarketing notice provision must be satisfied after the U.S. Food & Drug Administration (‘‘FDA’’) has approved the applicant’s biosimilar application. The short answer to both is no. However, other BPCIA-related questions and new questions raised by this decision still need to be resolved. Some strategic implications arising from this decision are considered below.

To read the full article, click on the PDF linked below.

Biosimilar-Product-Approval.PDF

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