Regulatory Focus™ > News Articles > AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars

AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars

Posted 15 February 2017 | By Zachary Brennan 

AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars

Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week.

“Retroactive application of the naming policy not only is unnecessary ‘for the proper performance of the functions of the agency,’ but it also is likely to undermine FDA’s objectives in adopting distinguishable nonproprietary names, i.e., to ensure safe prescribing and robust pharmacovigilance,” AbbVie said in a comment sent to FDA on Monday.


On 12 January, in a departure from the way WHO and Europe name biologics, FDA finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

The suffix is part of the agency’s plans to facilitate better pharmacovigilance for the originator biologics and their biosimilar counterparts.

FDA says: “The nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.”

And the random suffixes – companies will submit to FDA a list of 10 random suffixes for consideration – will be a requirement for all previously licensed originator biologics, related biological products and biosimilars.


In addition to the burden on sponsors to change already-licensed biologics and biosimilars, both Novartis and AbbVie said that changing the nonproprietary names of existing products does nothing to support safe prescribing or pharmacovigilance.

“We believe FDA’s naming convention for nonproprietary names of biologics is unnecessary for the purported reason of increased patient safety,” Novartis said. “Moreover, we believe such suffixes will not provide additional value beyond that of the current naming system, which has been used successfully for over six decades.”

Echoing those comments, AbbVie said that “requiring changes to the nonproprietary names of currently marketed products would impose significant burdens on industry, FDA, and the healthcare system that do not arise when manufacturers (of both biosimilars and originator products) are asked to adopt unique nonproprietary names before product approval.”

The American Society of Health-System Pharmacists (ASHP) also noted the burden of FDA’s plan for not just sponsors but others that would have to re-work their current systems to abide by FDA’s new policy.

“In practice, this change will require every segment of healthcare, including but not limited to hospitals, payers, and providers, to engage in thousands of hours of information technology redesign and reprogramming,” ASHP said in its comment posted Monday.

CVS Health, meanwhile, said FDA’s guidance could end up having “deleterious effects on the marketplace and could have a chilling effect on the development of affordable and accessible biosimilar products.

“By creating unique names, FDA could cause a situation where biosimilars with the same active ingredient, but without an identical INN [international nonproprietary name], would be in different categories than the originator product in provider databases… Each database warehouse would make these decisions independent of other warehouses, resulting in confusion and unnecessary complexity,” CVS added.

The Alliance for Patient Access, American Association of Clinical Endocrinologists, American Gastroenterological Association, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations and Endocrine Society also said in a comment sent to FDA on Monday that 80% of physicians support a meaningful, rather than random, suffix.

Comments on Nonproprietary Naming of Biological Products

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.