BioCentury
ARTICLE | Politics & Policy

U.S. government asserts biosimilars act preempts state law

September 15, 2017 10:24 PM UTC

On Monday, the U.S. government submitted an amicus brief to the U.S. Court of Appeals for the Federal Circuit (CAFC) in the case of Amgen Inc. v. Sandoz Inc. arguing that the federal Biologics Price Competition and Innovation Act (BPCIA) preempts state law, and thus state laws cannot be used to enforce participation in the BPCIA's disclosure process.

In a case between the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) and Amgen Inc. (NASDAQ:AMGN) 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 described in the BPCIA in which the biosimilar applicant and reference product sponsor exchange information, is not mandatory. ...