BioCentury
ARTICLE | Politics & Policy

Appeals court: Federal biosimilars act preempts state law

December 14, 2017 8:40 PM UTC

In a ruling issued in the case of Amgen Inc. v. Sandoz Inc. concerning biosimilars, the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the federal Biologics Price Competition and Innovation Act (BPCIA) preempts state law. Amgen Inc. (NASDAQ:AMGN) had sought to use California state law to force the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) to participate in patent notification procedures described in the BPCIA, but the CAFC ruled that the BPCIA preempts Amgen's state law claims.

In the case regarding marketing of Sandoz's Zarxio filgrastim-sndz, a biosimilar version of Amgen’s Neupogen filgrastim, the CAFC ruled in July 2015 that a biosimilar's required 180-day notification of commercialization must be filed after FDA approval and that the "patent dance," a process in which the biosimilar applicant and reference product sponsor exchange information, is not mandatory...