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Celltrion’s Rituximab Biosimilar Has Easy US FDA Panel Ride Despite Questions About Narrow Label

Executive Summary

Oncologic Drugs Advisory Committee says totality of evidence supports licensure of CT-P10 for three lymphoma indications, but panelists question what additional data would be needed to eventually get Rituxan’s other approved uses, which were carved out for patent and exclusivity reasons, onto the biosimilar’s label.

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