Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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...



US FDA Biosimilars Staff Faces More Transition As Sue Lim Departs After Christl

Sue Lim, who serves as director of scientific review staff of the US FDA's Therapeutic Biologics and Biosimilars Staff, will be leaving the agency at the end of February to start an independent consulting firm.

US FDA's Biosimilars Chief Leah Christl Plans Departure

A departure date has yet to be determined for the associate director of therapeutic biologics, who helped negotiate and implement the biosimilar user fee program.

Korea 2018 Review: Hopes And Worries Coexist In Pharma Sector

As the year end approaches, Scrip wraps up what major events made headlines in the South Korean pharma/biotech sector in 2018.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS124030

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