FDA Will Not Modify Names of Already Licensed Biologics

While the US Food and Drug Administration (FDA) plans to continue incorporating a four-letter suffix to nonproprietary names of new originator, biosimilar, and interchangeable biologic drugs, it is bowing out of an earlier plan to modify the names of biological drugs already licensed or approved without the suffix, said Scott Gottlieb, MD, FDA commissioner, in a March 7, 2019, statement.

The idea of modifying the names of existing biologics was proposed 2 years ago in an attempt to even the name presentation between biosimilars, which contain a four-letter suffix, and their originator products, which lack a suffix, according to a March 7, 2019, BioPharma Dive article.

“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,” Dr Gottlieb said. “After careful consideration, the FDA has determined that the crucial public health goals of the naming policy could still be accomplished by applying the naming convention to newly licensed biological products, while avoiding the negative consequences raised by extending the naming convention to previously licensed products.”

Going forward, the four-letter suffix will be applied to originator, biosimilar, and interchangeable biologic drugs to distinguish them at the pharmacy level and aid in the FDA’s ability to track adverse events. In fact, 27 originator biological products and 17 biosimilars already contain the suffixes, according to the FDA.

“As the FDA continues to apply this policy, we expect that a steadily increasing proportion of licensed biological products, including originator products, will have nonproprietary names that include four-letter suffixes,” Dr. Gottlieb said. “Of the biological products within the scope of the policy, only those originator products licensed prior to the implementation of the policy will lack a suffix.”

—Jolynn Tumolo