AbbVie, Novartis Unhappy With FDA Guidance on Naming Biologics and Biosimilars

AbbVie and Novartis are taking issue with the recent FDA final guidance on how biosimilars and their reference biologics are to be named. In comments about the posted guidance, the companies criticized the FDA’s naming convention, which requires retroactive changes to the nonproprietary names of existing biologics and biosimilars.

The FDA’s guidance specifies that product names are to include a four-letter meaningless suffix after a hyphen that follows the nonproprietary name. The suffix will be a requirement for all previously licensed originator biologics, related biological products, and biosimilars. The addition of the suffixes is part of the FDA’s plan to improve pharmacovigilance for reference biologics and their biosimilars.

“Retroactive application of the naming policy is not only 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, ie, to ensure safe prescribing and robust pharmacovigilance,” AbbVie commented.

Both Novartis and AbbVie said that changing the nonproprietary names of existing products does nothing to support safe prescribing or pharmacovigilance. Novartis disagrees that the revised naming system will improve patient safety. “We believe such suffixes will not provide additional value beyond that of the current naming system, which has been used successfully for over 6 decades,” Novartis added.

AbbVie believes that changing 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 originator and biosimilar products are asked to adopt unique nonproprietary names before product approval.

Other stakeholders also weighed in. CVS Health’s Vice President of Policy and Regulatory Affairs, Donald Dempsey, said the FDA’s guidance could have negative effects on the marketplace and slow the development of affordable and accessible biosimilars. The FDA’s rule to create unique names could cause a situation where biosimilars with the same active ingredient but not an identical international nonproprietary name would be in different categories than originator products in provider databases, “creating a situation where each database warehouse would make these decisions independently of other warehouses, resulting in confusion and unnecessary complexity.” The company also expects there to be an impact on member and client website and mobile applications, along with client reporting. “Our mail and specialty pharmacies systems will also be impacted by this guidance,” Dempsey said, and each will have to be carefully assessed and enhanced to avoid negative client and provider impacts or member disruption. CVS Health estimates this effort would cost in excess of $1 million.

The Biologics Prescribers Collaborative, which includes several patient and physician organizations, including the American Gastroenterological Association, Endocrine Society, and the Alliance for Patient Access, commented that 80% of physicians in their groups support a meaningful, not random, suffix to be used for the biosimilar name.

Jillanne M. Schulte, JD, director of Federal Regulatory Affairs for the Association of Health-System Pharmacists also commented on the burden of the FDA naming convention, not simply for drug makers but for others who would have to change current systems to work with the new policy. This would mean hospitals, payers, and providers would need to spend thousands of hours on IT redesign and reprogramming.