On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively. Wyost® and Jubbonti® are the first and only interchangeable denosumab biosimilars to be approved (in March 2024), and launched, in the US and have the same indications, dosage forms and routes of administration as Amgen’s denosumab products.
The US launch of Sandoz’s denosumab biosimilars follows a settlement agreement entered into by Sandoz and Amgen in April 2024 resolving US patent infringement litigation commenced by Amgen in May 2023 and permitting US launch of Wyost® and Jubbonti® from 31 May 2025.
Wyost® and Jubbonti® are approved in Europe (May 2024) and Australia (August 2024) and, in December 2024, they were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).
There are currently three other sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025) and Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025). Amgen settled patent litigation against Celltrion regarding denosumab biosimilars in January 2025, permitting US launch of Celltrion’s denosumab biosimilars from 1 June 2025 (Celltrion’s denosumab biosimilars have not yet been launched in the US at the date of this report). In March 2025, Amgen entered into a global settlement of its patent infringement litigation with Fresenius Kabi, allowing US launch of Fresenius’ denosumab biosimilars in mid-2025 (the precise date is unknown). BPCIA litigation commenced by Amgen against Samsung Bioepis and Accord/Intas regarding their denosumab biosimilars remains pending.