On 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing authorisation applications (MAAs) for its denosumab biosimilars for all indications of Regeneron’s Xgeva® and Prolia®. Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.
These acceptances follow the approval of Sandoz’s Jubbonti® and Wyost® (denosumab) in Europe in May 2024 and the EMA’s acceptance of MAAs for denosumab biosimilars of Fresenius Kabi (FKS518, May 2024) and Shanghai Henlius Biotech/Organon (HLX14, May 2024).
Denosumab biosimilars have also been approved in the US (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and MaiweijianTM).