FDA Approves mAbxience and Amneal's Denosumab Biosimilars

On December 22, 2025, mAbxience and Amneal Pharmaceuticals announced the FDA's approval of their Biologics Licensing Applications for two denosumab biosimilars. The approved drugs, Boncresa™ and Oziltus™, reference Amgen Inc.'s Prolia® and XGEVA® respectively. These biosimilars are anticipated to enhance access to affordable biologics for patients dealing with osteoporosis and oncology-related conditions.

Under the collaboration, mAbxience, partially owned by Insud Pharma, handles development and manufacturing. Amneal holds exclusive U.S. commercialization rights. The approval highlights mAbxience's scientific expertise and commitment to high-quality standards.

Both drugs must be administered by healthcare providers. Patients need monitoring for potential adverse reactions, such as hypocalcemia with Prolia® or dyspnea with XGEVA®.