Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Claims Sole Authority Over Naming Of US-Licensed Biologics

Executive Summary

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.

You may also be interested in...



US FDA Vs. USP: Regulator Sees Biologic Product Monographs As Barrier To Biosimilars

USP's proposed change aimed at harmonizing with FDA's suffix-based naming system for biologics would 'aggravate existing concerns' that biologic product-specific monographs are too inflexible and may impede development of biosimilars, agency says in a letter publicized through a tweet by the commissioner.

US FDA Vs. USP: Regulator Sees Biologic Product Monographs As Barrier To Biosimilars

USP's proposed change aimed at harmonizing with FDA's suffix-based naming system for biologics would 'aggravate existing concerns' that biologic product-specific monographs are too inflexible and may impede development of biosimilars, agency says in a letter publicized through a tweet by the commissioner.

How To Name A Biosimilar: Amgen Persisted With Amjevita Suffix Despite FDA Doubts

Drug Review Profile examines how Amgen persuaded US agency that its preferred distinguishable suffix choice for Amjevita, a biosimilar to AbbVie’s Humira, would not be confused with medical abbreviations or existing trademarks.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS119961

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