The staff of the Federal Trade Commission has submitted a comment to the U.S. Food and Drug Administration in response to the FDA’s request for comment on its draft guidance addressing nonproprietary names for biological products. The staff comment expresses concern that the FDA draft guidance on biosimilar naming may hinder competition, and recommends that the agency consider alternatives.
In its draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry,” the FDA proposes adding a new, random suffix to the nonproprietary name of each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.
Building on the FTC’s extensive experience in evaluating healthcare competition and studying competitive issues affecting biologics, the staff comment suggests that the FDA’s naming convention, which departs from the FDA tradition, may cause physicians to believe mistakenly that the products necessarily have clinically meaningful differences, potentially resulting in reduced price competition in biologic drug markets.
The comment also notes ways in which the naming proposal may create unnecessary costs, and conflicts with efforts toward global naming harmonization.
Finally, the comment asks the FDA to reconsider its proposal and suggests alternatives with less impact on competition that could achieve FDA’s purpose to avoid inadvertent substitution and improve the reporting of adverse events involving biologics to the FDA.
The Commission vote approving the staff comment was 4-0. (FTC File No. P131208; the staff contact is Elizabeth Jex, Office of Policy Planning, 202-326-3273)
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