FDA Response to Biosimilar Naming Petitions Just Issued

BioSimilars Patent Dance

BioSimilars Patent DanceOn January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their reference products distinguishable, nonproprietary names.

Today, the FDA published a follow up letter responding to the pending citizen petitions on the nonproprietary naming of biosimilar products. This letter concluded that the “GPhA and Novartis Petitions are denied, and the J&J Petition is granted to the extent it requests that biosimilar products have nonproprietary names that are similar to, but distinguishable from, the nonproprietary names of their reference products or of other biosimilar products.”

The letter further highlighted that under their final naming guidance the “FDA will designate nonproprietary names that consist of a core name (typically the name for the drug substance adopted by the USANC) with an FDA-designated suffix attached with a hyphen. Under this naming convention, the suffix designated in the nonproprietary name for newly and previously licensed originator biological products, related biological products, and biosimilar products will be a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. FDA is continuing to consider the appropriate suffix format for interchangeable products.

The FDA further stated that it believes the final naming convention will (1) facilitate pharmacovigilance and accurate identification for originator, related, and biosimilar biological products containing related drug substances, and (2) help minimize inadvertent substitution of any such products that have not been determined to be interchangeable.

Stay tuned to Big Molecule Watch for further updates.