On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”) resolving the BPCIA litigation regarding Accord’s denosumab biosimilar, INTP23. Pursuant to the agreement, Accord will be enjoined from making, using, selling, or importing its denosumab biosimilar into the U.S. market until October 1, 2025.
Denosumab is a human IgG2 monoclonal antibody that inhibits osteoclast activation, preventing the breakdown of bone. First marketed by Amgen as PROLIA® and XGEVA®, denosumab is used to treat conditions associated with bone loss, such as osteoporosis, and to treat bone cancers and prevent fractures in patients with bone metastases.
Amgen filed its BPCIA complaint against Accord on November 13, 2024 in the District Court for the Eastern District of North Carolina. It was the fifth denosumab biosimilar-related complaint filed by Amgen, following those against Sandoz, Celltrion, Samsung Bioepis/Samsung Biologics, and Fresenius Kabi. Sandoz settled with Amgen in April 2024.
On November 18, shortly after filing its complaint against Accord, Amgen moved to consolidate the four pending cases, Celltrion, Samsung Bioepis, Fresenius, and Accord, in the District Court for the District of New Jersey. The transfer order was entered on February 6, 2025, after a Consent Judgment and Injunction was entered in the case with Celltrion on January 23, 2025 but before the Celltrion case was resolved in April 2025. Fresenius settled with Amgen on March 7, 2025. The Samsung Bioepis case remains pending.
Following their respective settlements with Amgen, Sandoz launched its denosumab biosimilars, WYOST® and Jubbonti®, in June of this year while Fesenius launched Conexxence® and Bomyntra® and Celltrion launched STOBOCLO® and OSENVELT® in July of this year. Though not yet able to market denosumab biosimilars in the United States, Accord’s OSVYRTI® and JUBEREQ® received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April.
Meanwhile, Amgen filed three new denosumab biosimilar BPCIA complaints in June 2025 against Hikma Pharmaceuticals USA Inc., Shanghai Helius Biotech, Inc., and Biocon Biologics, Inc., bringing the total number of denosumab BPCIA litigations to eight.
Stay tuned to Big Molecule Watch for further developments in the denosumab BPCIA litigations and check out the BPCIA Litigations Tracker for updates on additional BPCIA cases.