Amneal’s Denosumab Biosimilars For Prolia® And XGEVA® Accepted For FDA Review, Decision Expected In 2025

Amneal Pharmaceuticals and mAbxience have announced that the U.S. Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for two denosumab biosimilars referencing Prolia® and XGEVA®. The FDA has set a target action date for the fourth quarter of 2025. mAbxience, a Fresenius Kabi majority-owned company with partial ownership from Insud Pharma, will handle development and manufacturing. At the same time, Amneal will oversee regulatory approval and commercialisation in the U.S. This marks a key step in Amneal’s expanding biosimilar portfolio. 

“Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics. Building on our first three successful biosimilar launches, we look to expand our portfolio next with denosumab, an important therapy across multiple indications, including oncology. We are pleased to expand our partnership with mAbxience as we advance our biosimilars pipeline,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.

Currently, Amneal markets three biosimilars in the U.S., and the denosumab biosimilars are expected to be the following additions. The company also has three more biosimilars in development, aiming to offer six biosimilars across eight product presentations by 2027. Denosumab, a monoclonal antibody, is used to prevent bone loss and fractures in osteoporosis and treat bone metastases from cancer. Amneal and mAbxience previously collaborated on ALYMSYS®, a bevacizumab biosimilar launched in 2022.

Jurgen Van Broeck, Chief Executive Officer of mAbxience, commented, “We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalisation strategy and applying innovation and cutting-edge R&D technology to create high quality, affordable medicines for underserved patients.” 

Prolia® is primarily used for postmenopausal osteoporosis, with common side effects including musculoskeletal pain and hypercholesterolemia. XGEVA®, used for bone metastases, has reported adverse effects such as dyspnea, fatigue, and hypophosphatemia. According to IQVIA, U.S. sales of Prolia® and XGEVA® reached approximately $5 billion in 2024, highlighting the market potential for Amneal’s biosimilars.