On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively. This will provide a streamlined reimbursement procedure for the products, effective 1 October 2025.
Conexxence® and Bomyntra® were FDA approved in March 2025 and launched in the US on 1 July 2025.
Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025. The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024. The global settlement permits European launch of Fresenius’ biosimilars at the end of November 2025. Conexxence® and Bomyntra® were approved in Europe in July 2025.