Amgen, Novartis biosimilars news
Novartis’ Sandoz Inc. generics unit filed a motion in the U.S. District Court for the Northern District of California seeking an order to dismiss patent infringement and related claims from Amgen related to Sandoz’s application to market Zarxio, a biosimilar of Amgen’s neutropenia drug Neupogen filgrastim recombinant methionyl human G-CSF.
In July, Sandoz announced FDA accepted a BLA for Zarxio, making it the first disclosed biosimilar candidate to reach that regulatory milestone in the U.S. In October, Amgen filed a lawsuit and a Citizen’s Petition alleging that Sandoz refused to follow the patent resolution protocol laid out by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) when it filed the BLA for Zarxio. BPCIA stipulates that a biosimilar applicant provide the reference product sponsor with a copy of the BLA and manufacturing information for its biosimilar within 20 days of FDA’s acceptance of the application for review. The procedure is designed to identify and resolve potential patent disputes before a biosimilar is approved and commercialized. In its Citizen’s Petition to FDA, Amgen alleged that Sandoz said it views the patent resolution procedure as “optional” (see BioCentury, Nov. 3, 2014 & Nov. 10, 2014). ...