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FDA Releases Guidance on Biologic, Biosimilar, and Interchangeable Biosimilar Naming Conventions


The FDA has issued an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

The FDA no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, according to an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

However, the new guidance explains that the agency will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products such as insulins, and once interchangeable biosimilars become a reality, the FDA will designate a proper name comprising the core name and a suffix. Any product first approved as a biosimilar and later determined to be interchangeable with its reference will keep its original nonproprietary name, inclusive of the suffix.

Additionally, the FDA is implementing an internal procedure for FDA staff to ensure consistency and transparency in the review process for suffixes, and it is considering whether it will extend its naming convention to vaccines.

In a statement, outgoing FDA Commissioner Scott Gottlieb, MD, acknowledged that there is considerable ongoing debate over the naming of biologics and biosimilars in the United States, particularly with respect to 4-letter suffixes that some stakeholders have deemed to be a hindrance to building confidence in biosimilars. In fact, other regulatory territories, such as Canada, have expressly opted for suffix-free naming conventions.

Gottlieb recognized in his comments that some stakeholders have called on the FDA to forego these suffixes in the interest of promoting biosimilar adoption. However, he said, “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.”

According to the FDA, the naming convention will allow the agency to effectively monitor all biologics to promote patient safety. “Even though biosimilars have no clinically meaningful differences from the reference product, these unique suffixes are a critical component of the FDA’s ability to track adverse events to a specific biological product and manufacturer so that appropriate action can be taken when needed to protect patients,” said Gottlieb. He added that, over time, patients and providers will increasingly understand that suffixes reflect a consistent naming convention, and that they are not a signal of inferior product quality.

As for the agency’s decision not to append suffixes to the names of already approved biologics, he noted that undertaking a name change would be costly. If costs were passed to patients, such an outcome would be contrary to the aims of the biosimilars program, which seeks to make biologic treatment less expensive for patients and the healthcare system.

The FDA will receive comments on the draft guidance over the next 60 days with a view toward issuing a final version of the guidance in the future.

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