BioCentury
ARTICLE | Politics & Policy

SCOTUS speeds biosimilars to market

June 12, 2017 9:58 PM UTC

A unanimous ruling issued Monday by the U.S. Supreme Court will shorten the timeline for biosimilars to reach the market by six months, and is likely to give the drugs' manufacturers flexibility to decline to participate in patent notification procedures specified in the Biologics Price Competition and Innovation Act (BPCIA).

The case, which pitted the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) against Amgen Inc. (NASDAQ:AMGN), involved marketing of Sandoz's Zarxio filgrastim-sndz, a biosimilar version of Amgen’s Neupogen filgrastim. The precedent set in the case will apply to pending and future biosimilars, Goodwin Procter LLP Partner William Jay told BioCentury. ...