Pink Sheet is part of the Business 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


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.


Related Content

Sandoz Tested Erelzi’s Suffix On Multiple Fronts
How Long Does It Take To Change A Name?
FDA Claims Sole Authority Over Naming Of US-Licensed Biologics
Biological Product Suffix Submissions Limited To 10 Candidates By US FDA
Biologic Product Naming: US FDA Sticks With Suffixes ‘Devoid Of Meaning’
Biosimilar Suffix Detractors Hope Private Studies Build Their Case
FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi
Biosimilar Naming: FDA Asked Celltrion For Two Kinds Of Suffixes


Related Companies




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