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US Denosumab Race Remains Busy As Amneal And mAbxience See Filing Accepted

Celltrion Just Became Third Firm To Win US Denosumab Approval; Many Other Chasers

 
• By Dean Rudge

Ahead of the first biosimilars to denosumab emerging later in the spring, the market is continuing to prove enticing, with Amneal the latest to file for biosimilars to Prolia and Xgeva.

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Amneal is looking ahead to a US Food and Drug Administration target action date in the fourth quarter of 2025 for its proposed mAbxience-partnered Prolia/Xgeva (denosumab) biosimilars, after they were accepted for filing by the agency.

The US-based firm said it looked forward to expanding its portfolio next with denosumab, “which is an important therapy across multiple indications, including oncology. We are pleased to expand our...

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