FTC Submits Comment on FDA Guidance Regarding Nonproprietary Naming of Biological Products

The Federal Trade Commission staff has responded to the Food and Drug Administration’s request for comment on its updated industry guidance regarding nonproprietary naming of biological products.

The FDA proposes to add a unique, meaningless suffix to the nonproprietary name of all biosimilar and interchangeable products and to any reference biologic approved after January 2017.

This comment and two prior comments to the FDA express the FTC’s concern that disparate treatment and differentiated naming of certain biosimilar products will reduce biosimilar competition in the United States.

The FDA’s proposed 2019 Updated Naming Guidance would likely create unnecessary barriers to entry for lower cost biologic products that are biosimilar to or interchangeable with existing FDA-approved biologic products, according to the FTC comment. As a result of this proposed guidance, these new entrants would likely face confusion and the perception of quality differences implied by the different name. The FTC comment notes that this change would subvert the procompetitive purpose of these lower cost medicines.

The Commission vote approving the comment to the FDA was 5-0. (FTC File No. V190001; the staff contact is Elizabeth Jex, Office of Policy Planning, 202-326-3273.)

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