Pink Sheet 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
UsernamePublicRestriction

With Biosimilar Statistical Guidance Withdrawn, Expect Sponsor-Specific Advice, FDA's Christl Says

Executive Summary

US FDA's biosimilar chief tells Pink Sheet that sponsors will receive more advice specific to their development programs based on their data package, a practice already in use in some cases.

You may also be interested in...



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.

Suffix Smackdown: Gottlieb Calls Issue 'Red Herring' For Biosimilars

'This is important for our own pharmacovigilance,' US FDA commissioner says. 'We still have an open question on whether or not we’re going to apply a suffix or change also the branded company’s name as well.'

Suffix Smackdown: Gottlieb Calls Issue 'Red Herring' For Biosimilars

'This is important for our own pharmacovigilance,' US FDA commissioner says. 'We still have an open question on whether or not we’re going to apply a suffix or change also the branded company’s name as well.'

Related Content

Topics

UsernamePublicRestriction

Register

PS123364

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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