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 Lines Up Denosumab Biosimilar Launch As FDA Says Yes To Filings
Fourth FDA Approval For Denosumab Biosimilar Comes Shortly After Settlement
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.
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