Kabi Lines Up Denosumab Biosimilar Launch As FDA Says Yes To Filings

Fourth FDA Approval For Denosumab Biosimilar Comes Shortly After Settlement

 
• By Dean Rudge

Fresenius Kabi has met its end of the bargain to launch biosimilars to Prolia/Xgeva in the middle of this year, after bagging FDA approvals. The German firm is also set to hear back on its filings in Europe imminently.

Prolia Denosumab Amgen
• Source: Shutterstock

Fresenius Kabi will look to launch its denosumab biosimilars to Prolia and Xgeva in the US in mid-2025, after the German firm received US Food and Drug Administration approval for the biosimilars – the company’s sixth FDA biosimilar approval.

Kabi’s Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), referencing Prolia and Xgeva respectively, become the fourth FDA-approved denosumab biosimilars, a year on from Sandoz receiving approval for its Jubbonti and Wyost versions.

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