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Celltrion Approvals Set Up Denosumab Showdown In US

Korean Firm Wins FDA Nod For Third Prolia And Xgeva Biosimilars

 
• By Dave Wallace

Celltrion has become the third firm to win FDA approval for US biosimilar rivals to Prolia and Xgeva. But with multiple denosumab competitors set to launch in just a couple of months, and several more candidates on the way, the market looks likely to be another competitive one for biosimilar sponsors.

Three approved denosumab biosimilars are preparing to face off in the US (Shutterstock)

Celltrion has become the third firm to win US Food and Drug Administration approval for biosimilar denosumab rivals to Prolia and Xgeva, with the agency approving the Korean developer’s CT-P41 candidate as Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), covering all indications of the respective brands.

Denosumab is one of the major molecules set to face biosimilar competition this year. Amgen’s two reference brands currently represent...

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