Amgen, Novartis autoimmune, biosimilars news
Amgen filed suit against Novartis’ Sandoz unit in the U.S. District Court for the District of New Jersey alleging that Sandoz’s biosimilar etanercept ( GP2015) infringes five patents covering Amgen’s autoimmune drug Enbrel etanercept, the reference product. The patents are U.S. Patent Nos. 8,063,182; 8,163,522; 7,915,225; 8,119,605; and 8,722,631. The complaint also states Sandoz has refused to follow the patent resolution protocol laid out by the Biologics Price Competition and Innovation Act (BPCIA). According to Amgen, Sandoz has failed to “engage in negotiation and exchange of patent lists” as specified by the BPCIA.
Amgen is seeking a judgment of infringement and an injunction to prevent Sandoz from marketing the biosimilar until the last of the five patents expires. The biotech requested a jury trial. FDA is reviewing a BLA from Sandoz for the biosimilar covering all of Enbrel’s approved indications. Amgen recorded $5.1 billion in 2015 U.S. sales of Enbrel, which is a recombinant p75 tumor necrosis factor (TNF) receptor linked to the Fc portion of human IgG1 (TNFr:Fc). FDA first approved Enbrel in 1998. ...