Celltrion’s Rituximab Biosimilar Has Easy US FDA Panel Ride Despite Questions About Narrow Label
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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Celltrion’s Rituximab Biosimilar Heads To Panel Review With US FDA Backing, Thanks To Additional Clinical Trial
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.
Pfizer is launching its second US biosimilar, a version of filgrastim, at an aggressive 30.3% discount to Amgen's branded Neupogen and at a discount to competing biosimilars.
Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.