FDA guidance for non-proprietary biologicals naming flawed, says FTC

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

The FDA proposes to add a unique, meaningless suffix to the non-proprietary 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 USA.