On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28% discount. Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.
KBR also reported on 19 March 2025, that Samsung Bioepis and Hanmi Pharmaceutical have entered into a joint sales agreement for Samsung Bioepis’ SB16, biosimilar to Amgen’s Prolia® (denosumab). Under the agreement, Samsung Bioepis will be responsible for the development and supply of the biosimilar, with both companies managing marketing and sales.
While Samsung Bioepis’ denosumab biosimilars have not yet been approved in Korea, they were approved in February 2025 in the US (Ospomyv™/Xbryk™) and Europe (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.