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In Response to a Request for Comments on Its Guidance for Industry on the 'Nonproprietary Naming of Biological Products'
Federal Trade Commission (10/27/15)
The staff of the Federal Trade Commission's (FTC's) Office of Policy Planning, Bureau of Economics, and Bureau of Competition suggests that the Food and Drug Administration (FDA) reconsider a proposal for nonproprietary names of biologic products. Under FDA's Draft Naming Guidance, a biological product licensed under the Public Health Service Act would have to carry a nonproprietary name that includes a unique, FDA-designated suffix. This is meant to improve pharmacovigilance and reduce substitution of biological products that are not interchangeable. FTC staff is concerned that assigning different suffixes to the drug substance names of biosimilars and their reference biologics could lead physicians to believe incorrectly that biosimilars' drug substances differ from reference biologics' substances in clinically meaningful ways. This may deter physicians from prescribing biosimilars and hinder the development of markets and competition for biosimilars. FDA's proposal also is not consistent with a proposal for biologic naming being considered by the World Health Organization, which "risks undermining international harmonization efforts," FTC staff write. Market participants have suggested alternatives, such as reliance on trade names and the use of the Purple Book to prevent inadvertent substitution by pharmacists.
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