Supreme Court to Address its First Biosimilars Dispute

Jan 23, 2017

National Law Review

The U.S. Supreme Court recently granted cross-petitions for certiorari in Sandoz Inc. v. Amgen and Amgen Inc. v. Sandoz Inc., marking the first time in which the Supreme Court will addresses issues arising under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The BPCIA establishes an expedited pathway for the FDA to approve biosimilar versions of drugs originally approved based on a biologic license application (BLA). At issue in this high stakes case is when the biosimilar applicant has to provide the statutory 180-day notice of commercial marketing to the original drug developer -- before or after the biosimilar’s approval by the FDA.

The case arose in 2014 out of Sandoz’s application for approval of a biosimilar to Amgen’s NEUPOGEN (filgrastim), when, according to Amgen, Sandoz did not provide appropriate notice to Amgen.

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