On November 6, 2025, Amgen, Inc. (“Amgen”) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy’s Laboratories (“Dr. Reddy’s”) and Alvotech, and the second against Amneal Pharmaceuticals (“Amneal”).
As we previously reported, the FDA accepted the BLA for Amneal’s denosumab biosimilar, MB09, on March 12, 2025, and for Dr. Reddy’s and Alvotech’s denosumab biosimilar, AVT03, on March 18, 2025. Both MB09 and AVT03 reference Amgen’s denosumab products, PROLIA® and XGEVA®. Denosumab is a RANK ligand (RANKL) inhibitor that is used to reduce the risk of bone fracture and skeletal-related events in patients with osteoporosis or cancer.
The complaints against Dr. Reddy’s/Alvotech and Amneal both assert a set of 31 patents, with the two sets largely overlapping. Amgen also alleges that the defendants in both cases failed to comply with § 262(l)(2)(A) by failing to disclose “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” In both cases, Amgen seeks a judgment of infringement, a permanent injunction barring future infringement until the expiration of the asserted patents, damages for post-verdict infringement, and attorneys’ fees.
These two new cases brought by Amgen are the nineth and tenth BPCIA litigations regarding denosumab, following Amgen’s litigations against Sandoz, Celltrion, Samsung Bioepis/Samsung Biologics, Fresenius, Accord Biopharma, Hikma Pharmaceuticals, Shanghai Henlius Biotech, and Biocon Biologics. Of the previously filed litigations, all but those against Hikma Pharmaceuticals and Shanghai Henlius Biotech have settled.
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