On 10 October 2024, STADA announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).
Under an agreement with Alvotech entered in June 2024, STADA has semi-exclusive rights to commercialise the Alvotech-developed AVT03 in Europe, Switzerland and the UK, and exclusive rights in certain Central Asian and Middle Eastern countries.
Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars to be approved in Europe in May 2024. The EMA accepted MAAs for denosumab biosimilars of Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), Shanghai Henlius Biotech/Organon (HLX14, May 2024), and Teva (October 2024)
Denosumab biosimilars have also been approved in the US (Sandoz’s Jubbonti® and Wyost®, March 2024), Canada (Sandoz’s Jubbonti®, February 2024 and Wyost®, March 2024), China (Boan Biotech’s Byoubei® (November 2022) and Boluojia® (May 2024) and Mabwell’s Mailishu® (March 2023) and Maiweijian™ (April 2024)).