On 1 July 2025, Fresenius Kabi announced the US launch of Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Fresenius’ denosumab biosimilars are the second to launch in the US, following the 2 June 2025 launch of Sandoz’s Wyost® and Jubbonti®.
The launch of Conexxence® and Bomyntra® follows a global settlement agreement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024. The global settlement permits European launch of the products “later in H2 of 2025”, subject to regulatory approvals. The US launch of Sandoz’s denosumab biosimilars similarly followed a settlement of US patent litigation commenced by Amgen.
There are currently two other sponsors with denosumab biosimilars approved in the US, which have not yet launched: Celltrion (Stoboclo® and Osenvelt®, approved March 2025), and Samsung Bioepis (Ospomyv™ and Xbryk™, approved February 2025). Amgen settled denosumab patent litigation against Celltrion in January 2025, permitting US launch of Celltrion’s Stoboclo® and Osenvelt® from 1 June 2025 (although launch has not yet occurred). BPCIA litigation commenced by Amgen against Samsung Bioepis regarding denosumab biosimilars remains pending.
Amgen also has pending US BPCIA litigation against Samsung Bioepis, Accord/Intas, Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.