On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®. The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively.
The US launch date for the newly approved biosimilars is uncertain given ongoing BPCI litigation regarding the products, commenced by Amgen in May 2023 relating to 21 patents.
The US approval comes weeks after Sandoz announced the approval of Jubbonti® in Canada. Prolia® biosimilars developed by Boan Biotech and Mabwell were approved in China respectively in November 2022 (BA6101, Byoubei®) and March 2023 (Mailishu®).