Amgen Appealing Decision That Allows First U.S. Biosimilar Entry

Amgen, in an expected move, is appealing a federal judge’s decision that cleared the way for Sandoz to launch Zarxio, its biosimilar of Amgen’s chemotherapy product Neupogen.

Both Amgen and Sandoz have agreed to an expedited appeal to the U.S. Court of Appeals for the Federal Circuit and will ask the court to set oral arguments for June on the patent case. Meanwhile, Amgen is also asking the lower court judge to bar Zarxio (filgrastim-sndz) from the market while the case is heard. Sandoz has agreed not to launch its biosimilar until at least May 11.

In its appeal, Amgen wants the court to overturn a U.S. District Court for the Northern District of California judge’s March 19 ruling in Amgen v. Sandoz that because the patents protecting Neupogen (filgrastim) have long since expired, Amgen is not entitled to an injunction blocking Sandoz from selling a biosimilar.

Amgen also wants the appellate court to reinstate dismissed claims alleging Sandoz has violated parts of the 2010 biosimilar law that it says mandate biosimilar applicants hand over their manufacturing process and other information to brandmakers in order to facilitate patent infringement litigation. Sandoz has countered that handing over that information is voluntary. So far, the judge has sided with Sandoz.

The California district judge stayed all other proceedings in the case until the appellate court renders a decision. — Bryan Koenig