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Celltrion’s Rituximab Biosimilar Heads To Panel Review With US FDA Backing, Thanks To Additional Clinical Trial

 
• By Sue Sutter

Non-inferiority study in advanced follicular lymphoma patients created uncertainty as to whether there were any clinically meaningful differences between CT-P10 and Genentech’s Rituxan, but a newly submitted, equivalence study appears to have put those concerns to rest for agency reviewers.  

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Celltrion Inc.’s resubmitted biosimilar application for CT-P10 appears to have addressed the US FDA’s first-cycle review concerns as to whether there are any clinically meaningful differences between the proposed biosimilar and its reference product, Genentech Inc.’s Rituxan (rituximab).

In briefing documents released ahead of an Oct. 10 Oncologic Drugs Advisory Committee meeting, FDA reviewers conclude the analytical data...

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