Amgen, Novartis biosimilars news

Earlier this month, Novartis’ Sandoz unit asked the U.S. Supreme Court to review a lower court’s interpretation of the Biologics Price Competition and Innovation Act that, if upheld, effectively delays the launch of a biosimilar until at least 180 days after FDA approval. Language in BPCIA requires the sponsor of a biosimilar to give the sponsor of the reference product 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. CAFC’s decision delayed the launch of Sandoz’s Zarxio filgrastim-sndz until September 2015. FDA approved the Zarxio, a biosimilar of neutropenia drug Neupogen filgrastim from Amgen, in March 2015 (see BioCentury, July 27, 2015 & Sept. 7, 2015). ...