SCOTUS to review biosimilar launch timelines

The U.S. Supreme Court granted a petition from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) to review a lower court's interpretation of the Biologics Price Competition and Innovation Act (BPCIA) that effectively delays the launch of a biosimilar until at least 180 days after FDA approval.

Language in the BPCIA requires the sponsor of a biosimilar to give the reference product's sponsor 180 days notice before the date of first commercial marketing of the biosimilar. The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled in July 2015 that the notice can be given only after FDA has approved the biosimilar. The ruling delayed the launch of Sandoz's Zarxio filgrastim-sndz, a biosimilar of Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, July 21, 2015)...