Another important milestone in the evolution of the biosimilars market appears close. Earlier this week, an FDA advisory committee overwhelmingly recommended approval of CT-P13, a biosimilar version of Johnson & Johnson's TNF-inhibitor Remicade developed by the Korean biotech Celltrion . Assuming the agency follows recommendation of the AdCom, it will be marketed in the U.S. by Pfizer, which obtained marketing rights via its acquisition of Hospira last year. Furthermore, AdCom recommendation extends to extrapolation of all seven indications for which Remicade is approved (recognizing orphan exclusivity will apply to one), based on Celltrion’s study data in just two of these indications.
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