On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab). This follows the South Korean approval of Samsung Bioepis’ Obodence™ (biosimilar to Amgen’s Prolia®) in April 2025.
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.