On 29 April 2024, each of Amgen and Sandoz announced that they resolved the US patent litigation regarding Sandoz’s denosumab biosimilars enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances.
This concludes the District Court proceedings Amgen commenced against Sandoz in New Jersey on 1 May 2023 alleging infringement of 21 patents relating to Amgen’s Prolia® and Xgeva®. The proceedings followed the FDA’s acceptance of Sandoz’s BLA for Jubbonti® and Wyost® in February 2023.
Jubbonti® and Wyost® were approved by the FDA on 5 March 2024 for all indications of, and as interchangeable with, Prolia® and Xgeva®, respectively. No other denosumab biosimilars have received US approval to date.
In March 2024, the CHMP of the European Medicines Agency adopted a positive opinion for Sandoz’s denosumab biosimilars. Jubbonti® was approved in Canada on 20 February 2024. Other denosumab biosimilars have been approved in China: Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023), both biosimilars to Prolia®, and Mabwell’s MaiweijianTM (denosumab 120mg) (April 2024), biosimilar to Xgeva®. Companies that have denosumab biosimilars under development include Samsung Bioepis, Celltrion, Alvotech, Intas, and Shanghai Henlius Biotech.