On 5 February 2026, Korea Biomedical Review reported that Korean headquartered HK inno.N has received approval from Korea’s Ministry of Food and Drug Safety for Izambia Prefilled Syringe and Denbrayce Injection, biosimilars to Amgen’s Prolia® and Xgeva® respectively.
HK inno.N entered an exclusive licence agreement with mAbxience in January 2023 for the commercialisation of the denosumab biosimilars. mAbxience’s Izamby® and Denbrayce® received European approval in July 2025.
Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved in Korea (November 2024). In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®. 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. Boryung launched Samsung Bioepis’ Xbryk® on 1 August 2025, following its regulatory approval in May 2025. Samsung Bioepis and Hanmi Pharmaceuticals announced their joint South Korean launch of Samsung Bioepis’ Obodence™ (reference: Prolia®) in July 2025.