On 26 August 2025, Abbott announced that it has secured regulatory approval for the first denosumab biosimilar, referencing Amgen’s Prolia®/Xgeva®, in Thailand.
Denosumab biosimilars have been approved and launched around the world and, in some countries, are the subject of pending litigation. For example:
- In the US, Sandoz (Jubbonti® and Wyost®, launched June 2025), Fresenius Kabi (Conexxence® and Bomyntra®, launched July 2025) and Celltrion (Stoboclo® and Osenvelt®, launched July 2025) all have denosumab biosimilars on the market. Samsung Bioepis’ Obodence™ and Xbryk™ were approved in February 2025. Amgen has pending US BPCIA litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA. On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.
- In Europe, there are 7 sponsors with denosumab biosimilars approved although none have been launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025) and Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025).
- In China, Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia®, was approved in November 2022, followed by Boluojia® (biosimilar to Xgeva®) in May 2024. Mabwell’s Maiweijian™ (biosimilar to Amgen’s Xgeva®) received marketing approval in April 2024.
- In Korea, Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved (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.
- In Canada, Sandoz launched Jubbonti® and Wyost® in July-August 2024.
- In Australia, Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars approved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025). Jubbonti® and Wyost® were PBS-listed and launched in Australia in August 2025. Amgen commenced patent infringement against Sandoz in Australia in relation to its denosumab biosimilars in June 2025.