August 7, 2017
Authored and Edited by Thomas J. Sullivan; William B. Raich, Ph.D.
On January 12, 2017, FDA released a final Guidance for Industry, Nonproprietary Naming of Biological Products. The Guidance sets forth a nonproprietary naming convention that “includes an FDA-designated suffix” of four lowercase letters of which at least three are distinct and a core name, with the combination devoid of any meaning. According to FDA, this naming convention is both prospective and retrospective—applying to “originator product[s], related biological product[s], and biosimilar product[s].”
Less than one week after FDA released this Final Guidance, it published a letter in response to three pending citizen petitions on nonproprietary naming of biosimilar products. The citizen petitions from the Generic Pharmaceutical Association (“GPhA”) and the Novartis Group requested that biosimilar products share the same nonproprietary name as their reference products. The citizen petition from Johnson & Johnson requested that biosimilar products be given nonproprietary names that are similar, but distinguishable from, those of their reference products or other biosimilar products. FDA’s letter denied both GPhA’s and Novartis’s petitions but granted Johnson Johnson’s petition only to the extent that biosimilar products may have similar, but distinguishable, nonproprietary names. The letter further emphasized that under this Final Guidance, the FDA-designated suffix for all originator biological products, related biological products, and biosimilar products will be the distinguishing component of their nonproprietary names.
Further discussion of the decision can be found on Finnegan’s IP Updates.
Biologic License Application (BLA), abbreviated biologic license application (aBLA), Food and Drug Administration (FDA)
Copyright © 2017 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. Please do not post any information that you consider to be personal or confidential. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. Contact us for additional information. One of our lawyers will be happy to discuss the possibility of representation with you. Additional disclaimer information.
Conference
2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities
March 20, 2024
Boston
At the PTAB Blog
IPR and PGR Statistics for Final Written Decisions Issued in January 2024
March 7, 2024
Webinar
February 15, 2024
Webinar
At the PTAB Blog
IPR and PGR Statistics for Final Written Decisions Issued in November and December 2023
February 2, 2024
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.