Amgen and Sandoz Settle Denosumab BPCIA Litigation

As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab Litigation”).  The FDA subsequently, in March 2024, approved Sandoz’s denosumab biosimilars, WYOST (denosumab-bbdz) and JUBBONTI (denosumab-bbdz), as interchangeable with Amgen’s XGEVA and PROLIA products.

On April 29, 2024, the District of New Jersey signed off on the parties’ agreed-to stipulation to dismiss the Sandoz Denosumab Litigation.  The stipulation states, among other things, that the parties entered into a confidential settlement wherein “the Parties agreed that the Sandoz Biosimilar Products infringe [U.S. Patent No. 7,364,736] and that the Boyle ’736 Patent is valid and enforceable as to the Sandoz Biosimilar Products”; and that, subject to the terms of the confidential settlement, “Sandoz is hereby enjoined from making, using, offering to sell, or selling Jubbonti or Wyost in the Territory [including the United States], or importing Jubbonti or Wyost into the Territory” and the “foregoing injunction expires on February 19, 2025.”

There are no other pending litigations on denosumab biosimilars, although, as we previously reported, Celltrion submitted an application to the FDA in November 2023 for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA.

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