On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA™ (denosumab-mobz) and OZILTUS™ (denosumab-mobz), biosimilars referencing Amgen’s PROLIA® (denosumab) and XGEVA® (denosumab), respectively. Under Amneal’s partnership with mAbxience, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive U.S. commercialization rights to the denosumab biosimilars.
BONCRESA and OZILTUS are the ninth set of denosumab biosimilars to receive approval from the FDA, following approvals for denosumab biosimilar products from Sandoz, Samsung Bioepis, Celltrion, Fresenius, Shanghai Henlius, Biocon, Hikma, and Accord.
As we previously reported, on November 6, 2025, Amgen filed a BPCIA complaint against Amneal and mAbxience alleging that their denosumab biosimilars infringe upon 31 patents. The case remains pending in the U.S. District Court for the District of New Jersey.