Amgen Files BPCIA Complaint Against Sandoz Regarding Denosumab

On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®.  This is Amgen’s first BPCIA case filed with respect to a denosumab biosimilar.  According to Amgen, PROLIA is “prescribed to treat patients with a high risk of bone fracture in certain settings, for example patients suffering from osteoporosis,” and “XGEVA is prescribed to prevent skeletal-related events (e.g., fractures or spinal cord compression) in cancer patients whose cancer has spread to the bone, as well as to treat certain types of tumors.”

Amgen seeks a declaratory judgement of infringement of twenty-one patents that, according to Amgen, “cover denosumab (the active ingredient in Prolia and XGEVA) and methods of manufacturing denosumab and denosumab products.”  Two of the asserted patents are directed to denosumab by its amino acid sequence, polynucleotides encoding it, and methods of making it. The remaining nineteen patents are directed to methods of manufacturing antibodies.  Amgen also seeks a permanent injunction against the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Sandoz’s denosumab biosimilar product.

Stay tuned to Big Molecule Watch for further developments with this case and check out the BPCIA Litigations Tracker for updates on additional BPCIA cases.