The FDA is updating its guidelines on naming biosimilar drugs. Misconceptions regarding biosimilar safety motivated a 2017 initiative to add four-letter suffixes to the proper names of both biosimilar and originator products.
After reviewing the potential cost to the healthcare system, which would eventually affect consumers, the FDA has decided to update its plans.
“We strongly believe in the ability of biosimilars to promote competition, lower prices and foster greater access,” says Scott Gottlieb, MD. “We’re fully committed to the suite of announced and upcoming policies to help advance the goal of a robust, high-quality, competitive market for biosimilar products. But I do not believe that the naming convention should be used to advance these goals if it could come at the expense of the ability to ensure patient safety. Nor do I believe the inclusion of a suffix will frustrate the broader aim of inspiring strong biosimilar competition.”
Per the update released on March. 7, the proper names of biological products licensed or approved under the Public Health Service Act without a FDA-designated suffix in their proper names will retain their current naming system.
Additionally, the FDA says that it does not intend to apply the naming convention to the proper names of transition biological products.
To further distinguish interchangeable biosimilars from originator and biosimilar products, the FDA says that it will designate a proper name that is a combination of the core name and a distinguished, four-letter suffix. The purpose of the suffix is to ensure that any adverse events are tracked to the correct product, either originator or biosimilar.
“We expect that as time goes on, and more biological products are introduced to the market with distinguishable suffixes, patients and providers increasingly will understand that the suffixes reflect a consistent naming convention and are not an indicator of product quality,” Gottlieb says. “What’s important to remember is that biosimilars have been proven to be highly similar and have no clinically meaningful differences, and the FDA continues to engage in efforts to promote this understanding.”
The new naming system is anticipated to improve FDA postmarket pharmacovigilance, increase the specificity of adverse report tracking, and improve the distinguishability of products at the pharmacy-level.