District Court Denies Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

The first U.S. biosimilar is one step closer to entering the marketplace. Last week, U.S. District Judge Richard Seeborg of the Northern District of California denied Amgen's request for a preliminary injunction to block Sandoz from selling its version of Neupogen. The Food and Drug Administration approved Sandoz’s biosimilar application for “Zarxio” earlier this month. Amgen had argued that Sandoz should have provided its Biologic License Application and manufacturing plans within 20 days after the FDA accepted the application, in accordance with the "patent dance" procedure laid out in the biosimilar statute. Amgen also argued that Sandoz should have provided six-months notice of its plans to market an FDA approved biosimilar.  Judge Seeborg’s concluding remarks sums up his view: “As the twelve-year exclusivity period for Neupogen long ago expired, there exists no substantive bar to market entry for Sandoz’s biosimilar filgrastim—and, consequently, no basis on which Amgen is entitled to injunctive relief or other remedies for disadvantages it may suffer due to market competition from Sandoz.” Background Sandoz’s biosimilar of Neupogen is the first application to be approved using the new biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA). This path allowed Sandoz to reduce the costs associated with bringing its drug to market if they could show their Neupogen-copy was “biosimilar” to the already a...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs