Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®

Core Viewpoint - Amneal Pharmaceuticals and mAbxience have received FDA approval for two denosumab biosimilars, Boncresa™ and Oziltus™, enhancing Amneal's biosimilars portfolio and positioning in the market for affordable medicines [1][3][4] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company focused on developing, manufacturing, and distributing a diverse portfolio of over 290 pharmaceuticals, with a significant emphasis on biosimilars and injectables [9] - mAbxience specializes in the development and commercialization of biopharmaceuticals, with a mission to provide accessible and affordable medicines globally [11] Product Details - Denosumab is a monoclonal antibody used to inhibit bone resorption, relevant in oncology and osteoporosis-related conditions [2] - The FDA-approved biosimilars Boncresa™ and Oziltus™ reference Prolia® and XGEVA®, respectively, which had combined U.S. annual sales of approximately $5.3 billion for the 12 months ending October 2025 [8] Strategic Importance - The introduction of these biosimilars marks a significant milestone for both Amneal and mAbxience, reflecting their commitment to high-quality standards and expanding access to affordable biologic medicines in the U.S. [4] - Amneal aims to commercialize six biosimilars across eight presentations by 2027, indicating a strong growth strategy in the biosimilars market [10]