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's Biologics Naming Plan: Industry Wants 'Memorable' Suffixes

Executive Summary

Random letter-based suffixes will make it difficult for prescribers and patients to identify a given product, biopharma companies say, requesting that suffixes be derived from the license-holder's name; GPhA, Federal Trade Commission say FDA plan for distinguishable names will create confusion and uncertainty.

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New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to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

ID1128360

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