On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab).
Obodence™ is Samsung Bioepis’ 10th biosimilar to be approved in South Korea, including following Epyztek® (ustekinumab) in April 2024, Afilivu® (aflibercept) in February 2024, and Episcli® (eculizumab) in January 2024.
Samsung Bioepis’ denosumab biosimilars were approved in February 2025 in both the US (marketed as Ospomyv™/Xbryk™) and Europe (marketed as Obodence™/Xbryk™). In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars. Those proceedings are ongoing.