Ruling Allows Sandoz’s Newly Approved Neupogen Biosimilar Launch
Nothing is stopping Sandoz from launching the first U.S. biosimilar, now that a federal judge has denied Amgen’s bid for an injunction blocking the alternate version of its blockbuster chemotherapy product Neupogen.
The U.S. District Court for the Northern District of California ruled last week that because Neupogen (filgrastim) has long since lost its patent protection, Amgen has no grounds for an injunction blocking the biosimilar, approved under the brand name Zarxio (filgrastim-sndz).
Perhaps as important, the judge struck down Amgen’s bid to require Sandoz to again provide 180 days advance notice before it goes to market, paving the way for the biosimilar to hit shelves immediately. Sandoz gave Amgen the required notice in July, but Amgen argued unsuccessfully that it was prohibited until after FDA approval. The agency signed off on the therapy earlier this month.
Amgen plans to appeal the decision in Amgen v. Sandoz. Sandoz, which last week declined to give a launch date, had planned to go to market as early as April 10.
The judge also dealt a serious blow to Amgen’s claims that Sandoz is required by law to hand over information on its manufacturing process as part of the so-called biosimilar “patent dance.”
Sandoz had sought additional confidentiality protections before turning over that data, but was rebuffed by Amgen. In response to Amgen’s lawsuit, Sandoz argued that handing over the manufacturing data is voluntarily and not a requirement of the 2010 law that created the biosimilar pathway.
In a blow to other brandmakers trying to force their biosimilar competition to hand over manufacturing information, the judge interpreted the law as creating disclosure procedures that drugmakers can choose to take advantage of, or not.
Legal experts see the manufacturing information as an important part of biosimilar litigation. Without it, brandmakers may have difficulty determining which of their product patents to assert in infringement litigation. — Bryan Koenig