On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, “Biocon”) after Amgen and Biocon executed a Confidential Settlement Agreement.
As we reported previously, Amgen filed its BPCIA complaint against Biocon on June 30, 2025, asserting 34 patents. At issue were Biocon’s denosumab biosimilars BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq), which reference Amgen’s PROLIA® and XGEVA®, respectively. The FDA approved both biosimilars on September 16, 2025, for all indications of their reference products. In the Consent Judgment, Biocon agreed that all 34 asserted patents are “valid, enforceable and infringed” by Biocon’s denosumab biosimilars. All other claims and counterclaims were dismissed with prejudice. The parties agreed that Biocon was permitted to launch its biosimilars on October 1, 2025. The Consent Judgment did not disclose any other terms of the Confidential Settlement Agreement.
The complaint against Biocon was the eighth denosumab BPCIA litigation initiated by Amgen and the sixth to be settled, following settlements with Sandoz, Celltrion, Fresenius, Accord BioPharma, and Samsung Bioepis. Amgen’s denosumab BPCIA cases against Hikma Pharmaceuticals USA Inc./Gedeon Richter and Shanghai Henlius Biotech/Organon, filed in June 2025, remain pending.
Stay tuned to Big Molecule Watch and follow our BPCIA Litigations Tracker to stay up to date on denosumab and other BPCIA litigation news.