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

FDA Biosimilar Naming Policy Takes Middle-Of-The-Road Approach

This article was originally published in The Pink Sheet Daily

Executive Summary

Most biologics will have random four-letter suffix added to nonproprietary name, but FDA asks a number of questions about potential alternatives.

You may also be interested in...



How Might FDA Be Convinced To Change Biosimilar Naming Policy?

Following FDA/FTC workshop, several stakeholders urge FDA to do away with suffixes for biosimilar names while others seek reconsideration of switching studies for interchangeability.

Biosimilar Competition: How Might FDA Be Convinced To Change Its Naming Policy?

Following FDA/FTC workshop, several stakeholders urge FDA to do away with suffixes for biosimilar names while others seek reconsideration of switching studies for interchangeability.

Policy Reversal: FDA Will No Longer Require Suffixes For Older Biologics

New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to attach suffixes to future approvals.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS078529

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