FDA Approves Amneal and mAbxience Denosumab Biosimilars

Reuters2025-12-23

FDA Approves Amneal and mAbxience Denosumab Biosimilars

Amneal Pharmaceuticals Inc., in partnership with mAbxience, has received FDA approval for its Biologics Licensing Applications (BLAs) for two denosumab biosimilars: Boncresa™ (denosumab-mobz), referencing Prolia®, and Oziltus™ (denosumab-mobz), referencing XGEVA®. mAbxience is responsible for the development and manufacturing of these biosimilars, while Amneal holds exclusive U.S. commercialization rights. This approval marks a significant milestone for both companies, expanding access to affordable biologic medicines in the United States.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amneal Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: EN52462) on December 22, 2025, and is solely responsible for the information contained therein.

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