Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

You may also be interested in...



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 Launches Nivestym At An Aggressive Discount To Other Filgrastim Products

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.

Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB002444

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel