Morningstar

Amneal, mAbxience Get FDA Approval For Two Biosimilars

Provided by Dow Jones

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)


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