On 30 June 2025, Amgen filed BPCIA litigation against Biocon in the in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.
The litigation follows Biocon’s submission of a Biologics Licence Application to the FDA for Bmab 1000, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).
The filing of the Biocon Complaint means Amgen now has five US proceedings pending regarding denosumab biosimilars, with litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon commenced on 25 June 2025 and proceedings against Accord/Intas and Samsung Bioepis commenced in November 2024 and August 2024, respectively.
Amgen has settled three other US denosumab disputes over the last 18 months. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025. Jubbonti® and Wyost® were launched in the US on 2 June 2025. Amgen settled its US litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025 (although launch has not yet occurred). In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025.