Amneal Pharmaceuticals Gets FDA's Approval For Biologics Licensing Applications For Boncresa, Oziltus

Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ:AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®, and Oziltus™ (denosumab-mobz), a biosimilar referencing XGEVA®.

Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related conditions. Under Amneal's partnership with mAbxience, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive U.S. commercialization rights.