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Amneal, mAbxience Get FDA Approval For Two Biosimilars

Provided by Dow Jones Dec 22, 2025, 9:29:00 PM

By Elias Schisgall

Amneal Pharmaceuticals and mAbxience received Food and Drug Administration approval for two biosimilars.

The companies said Monday that the FDA greenlit Biologics Licensing Applications for Boncresa, a biosimilar referencing Prolia, and Oziltus, a biosimilar referencing Xgeva.

The two drugs are based on denosumab, an antibody used for oncology and osteoporosis-related conditions. Amneal has commercialization rights in the U.S., while mAbxience, a company majority owned by Fresenius Kabi with a stake from Insud Pharma, is responsible for development and manufacturing.

Chirag and Chintu Patel, Amneal's co-chief executives, said the company now has five commercial biosimilars, adding that they see potential for major long-term growth in biosimilars.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

December 22, 2025 16:29 ET (21:29 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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