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Celltrion Settlement Puts Prolia And Xgeva Biosimilars On Ice – But Only Until June

Korean Firm Yet To Receive FDA Approvals Following November 2023 Filings

 
• By Dean Rudge

Celltrion has shaken hands with Amgen on a settlement agreement for its proposed US rivals to Prolia/Xgeva, as it continues to await approval from the US FDA for its biosimilar denosumab candidates.

Close up of old English dictionary page with word settlement - Image
• Source: Shutterstock

Celltrion looks set to be able to launch a biosimilar to Amgen’s Prolia/Xgeva (denosumab) in the US beginning on 1 June 2025 after settling patent-litigation proceedings with the originator – although, crucially, the firm is yet to pick up US Food and Drug Administration approval for its CT-P41 denosumab candidates.

According to a consent judgment and injunction signed by a judge in a federal district court in New Jersey, Celltrion...

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