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

Sandoz Tells FDA Unique Biosimilar Names OK… Sometimes

Executive Summary

If biosimilar sponsor doesn’t want brand name, nonproprietary name should have suffix, Sandoz says in update to its citizen petition.

You may also be interested in...



FDA Claims Sole Authority Over Naming Of US-Licensed Biologics

Deferring to nonproprietary names established by US Pharmacopeia without exercising independent judgment ‘would be untenable,’ FDA says in citizen petition response to industry; agency offers statutory defense of decision to require distinguishable suffixes for all novel biologics and biosimilars.

FDA Claims Sole Authority Over Naming Of US-Licensed Biologics

Deferring to nonproprietary names established by US Pharmacopeia without exercising independent judgment ‘would be untenable,’ FDA says in citizen petition response to industry; agency offers statutory defense of decision to require distinguishable suffixes for all novel biologics and biosimilars.

Biosimilar Suffix Detractors Hope Private Studies Build Their Case

Consortium’s biosimilar pharmacovigilance could provide data foundation to pressure FDA that suffixes are not needed in non-proprietary names.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1125120

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