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

Biologic Product Naming: US FDA Sticks With Suffixes ‘Devoid Of Meaning’

Executive Summary

Final guidance adds new factors for biosimilar and innovative sponsors to consider in developing distinguishable suffixes for nonproprietary names but FDA is unswayed by calls for meaningful suffixes derived from license holder’s name; timing of retrospective application to previously approved products remains in question.

You may also be interested in...



FDA Biosimilars Acting Director Yim Is ‘Not A Great Fan’ Of Suffix-Based Naming Policy

Whether one accepts the view that concerns about active pharmacovigilance and the need to distinguish small molecules from biologics support the controversial nomenclature system is ‘a personal thing,’ Sarah Yim says.

US FDA Biosimilars Acting Director Yim ‘Not A Great Fan’ Of Suffix-Based Naming Policy

Whether one accepts the view that concerns about active pharmacovigilance and the need to distinguish small molecules from biologics support the controversial nomenclature system is ‘a personal thing,’ Sarah Yim says.

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New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to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

LL1133145

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