On 11 July 2024, Fresenius Kabi announced that its Marketing Authorisation Applications (MAAs) for denosumab have been accepted for review by the European Medicines Agency (EMA) as biosimilars to, and for all indications of, Amgen’s Prolia® and Xgeva®.
This comes after Fresenius’ BLA for denosumab was accepted for review by the US FDA on 27 May 2024, as biosimilar to Amgen’s Prolia®. In June 2024, Fresenius presented results of a Phase 3 study demonstrating biosimilarity of its FKS518 (denosumab) with Amgen’s Prolia®.
Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and MaiweijianTM).