Amneal and mAbxience Secure FDA Review for Denosumab Biosimilars

• Amneal Pharmaceuticals and mAbxience announced that the U.S. FDA has accepted the Biologics License Application (BLA) for their two proposed denosumab biosimilars, referencing Prolia and XGEVA.

• The FDA has set a target action date in Q4 2025, with Amneal aiming to expand its biosimilar portfolio to six by 2027.

Amneal Pharmaceuticals, Inc. and mAbxience have received FDA acceptance for the review of their Biologics License Application (BLA) for two proposed denosumab biosimilars, referencing Prolia and XGEVA. The FDA has assigned a target action date in the fourth quarter of 2025.

Denosumab is a monoclonal antibody that inhibits bone resorption and is used to treat bone metastases from cancer and osteoporosis-related injuries. Under the agreement, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive U.S. commercialization rights and will lead regulatory approvals.

Currently, Amneal commercializes three biosimilars in the U.S. and has three more in development. If approved, the denosumab biosimilars will contribute to its goal of having six biosimilars across eight product presentations by 2027.

“Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.

Jurgen Van Broeck, Chief Executive Officer of mAbxience, stated, “Our partnership with Amneal has been strong and successful for many years, and we are excited to bring these two key products to the U.S. biosimilar market. We continue to focus on our global expansion strategy, leveraging innovation and advanced R&D technology to develop high-quality, affordable medicines for patients in need.”

According to IQVIA, U.S. annual sales for Prolia and XGEVA were approximately $5.0 billion as of December 2024. The partnership builds on Amneal and mAbxience’s existing collaboration, which includes ALYMSYS, a bevacizumab biosimilar launched in 2022.