Fresenius Follows US Denosumab Filing With EU Acceptance

EMA Accepts Firm’s Applications For Biosimilar Rivals To Prolia And Xgeva

Fresenius Kabi’s denosumab biosimilar filing has been accepted by the European Medicines Agency, coming hot on the heels of a US submission.

EMA
Fresenius has filed its denosumab biosimilars with the EMA

Fresenius Kabi has taken a step towards securing European rivals to Amgen’s Prolia/Xgeva (denosumab) brands after the European Medicines Agency accepted Kabi’s biosimilar filings for review.

The submissions come shortly after Fresenius filed denosumab biosimilars with the US Food and Drug Administration

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