FTC staff air concerns on FDA biologics naming plans

The staff of the US Federal Trade Commission has submitted a comment to the Food and Drug Administration in response to the FDA’s request for comment on its draft guidance addressing non-proprietary names for biological products.

The staff comment expresses concern that the FDA draft guidance on biosimilar naming may hinder competition, and recommends that the agency consider alternatives.

In its draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry,” the FDA proposes adding a new, random suffix to the non-proprietary name of each biological product. The purpose of the FDA’s naming convention is to improve pharmacovigilance and minimize possible inadvertent substitution of biological products that the FDA has not determined to be interchangeable.