Pink Sheet is part of the Informa Intelligence Division 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

Interchangeable Biosimilars: FDA Clarifies US Reference Not Mandatory For Studies

Executive Summary

Draft guidance strongly recommends against it, but US FDA's Leah Christl says agency is willing to talk about using foreign-licensed comparators.

Advertisement

Related Content

Biosimilar Interchangeability Switching Studies May Use Foreign Comparators, US FDA Says
Biosimilar Bridging Study Waivers: Public Health Prerogative Or Trade Secret ‘Taking’?
Biosimilar Bridging Study Waivers: Public Health Prerogative Or Trade Secret ‘Taking’?
Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching
Biosimilar Firms Fight Against 'Whisper Campaign' On Interchangeability
Humira Biosimilar Interchangeability: The Race Begins
US Comparator Requirement For Interchangeable Biosimilars Would Hurt Industry
Biosimilars: Postmarketing Data Alone Not Enough For Interchangeability
Biosimilar Interchangeability May Be Losing Luster As Approval Goal
Sandoz's Multi-Switch Biosimilar Trials: A View To Interchangeability?

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS121847

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