FDA Issues Biosimilar Naming Guidance

Shakespeare once said that a rose by any other name would smell just as sweet-but a recent statement released by FDA Commissioner Scott Gottlieb, MD, outlining new guidance on how these products should be named, has many players in the biosimilar industry worried that a four-letter suffix added to biosimilar names will make the products seem less clinically effective than their originator biologic counterparts.

In a lengthy statement released on March 7, Gottlieb reversed course on nomenclature guidelines released late last year, stating the agency no longer intends to change the proper names of licensed and/or approved biological products. Instead, they intend to designate a proper name for all interchangeable biosimilar drugs, merging the product’s core name with a specialized lower-case, four-letter suffix “devoid of meaning.” Notably, original biologic drugs will not have any suffixes attached to their names.

“After the FDA issued its 2017 guidance on biologics naming, we heard the concerns from stakeholders that one aspect of the policy-changing the names of older biologics to add suffixes-would impose substantial costs on the healthcare system and had the potential to create confusion that could increase risks to patients as drug names don’t often change after drugs go to market,” Gottlieb wrote.

He added that the addition of this suffix will help the FDA better monitor biosimilar drugs once they hit the market-and that the decision to change their guidance was in no way meant to suggest quality or efficacy differences between biologic and biosimilar products.

“In advancing consistency in the convention for naming all newly licensed biologicals-be it originator, biosimilar or interchangeable products-we aim to mitigate the risk of false perceptions from health care providers and patients that there’s a difference in the relative safety and effectiveness of these biological products based on their name,” he stated. 

Related: The State of Biosimilars in 2019

But not everyone is convinced the new policy is a sound one. The Biosimilars Forum, an industry group with the mission of expanding access and awareness to biosimilar products, immediately released a statement calling the announcement “a direct blow to biosimilar uptake in the U.S.”

“The decision abandons the retrospective addition of a suffix to origination biologics, leading to an unsubstantiated notion that strict pharmacovigilance is only essential for biosimilars,” they argue. “This decision will disincentivize biosimilar uptake at a time when the government should be implementing policies that incentivize the use of biosimilars, as they are one solution to help attack rising healthcare costs.”

Julie Rubin, PharmD, BCPS, director of clinical services for CompleteRx, a pharmacy management consultancy firm, says that having an industry standard for biosimilar nomenclature would be a boon-and help payers and physicians choose appropriate agents for patients.

“Right now, with naming, there’s no standard and it’s hard to differentiate between agents,” she says. She stated adding a suffix to the root of the originator biologic drug can help payers and providers identify the appropriate biosimilars-making them more likely to be added to payer formularies.

All parties, regardless of their stance on biosimilar naming conventions, agree that biosimilars are uniquely poised to promote drug competition, increase access to treatments, and lower skyrocketing healthcare costs. Similarly, they are all committed to promoting pharmacovigilance and patient safety, for all biological products. But, that said, the debate on appropriate nomenclature is likely to continue. While the FDA stated their updated guidance statement sets “a clear path” for naming, it remains a work in progress. The agency hopes that, with the publication of the statement, they will receive additional input regarding any concerns before issuing a final Nonproprietary Naming of Biological Products guidance document before the end of the year.

Kayt Sukel is a science and health writer based outside Houston.