On 1 September 2025, Searl announced that it has gained approval from Pakistan’s Drug Regulatory Authority to market and sell its denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®.
In July 2023, Searle entered into a licence agreement with China’s Mabwell Pharmaceuticals, under which Searle will manufacture, register and supply the biosimilars in Pakistan.
Denosumab biosimilars have been approved and launched around the world and, in some countries, are the subject of pending litigation. For example:
• 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.
• 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).
• 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.
• 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.
• Canada: Sandoz launched Jubbonti® and Wyost® in July-August 2024.
• Australia: Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilarsapproved 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.