FTC comments on FDA biosimilar naming guidance

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WASHINGTON — The staff of the Federal Trade Commission has submitted comment for the Food and Drug Administration’s draft guidance on nonproprietary names for biological products.

pharmacy-2The FTC said Wednesday that its staff comment expressed concern that the FDA draft guidance on biosimilar naming may hinder competition and, as a result, recommended that the agency consider alternatives.

In its draft guidance, titled “Nonproprietary Naming of Biological Products: Guidance for Industry,” the FDA proposed adding a random suffix to the nonproprietary name of each biological product to improve pharmacovigilance and minimize the possibility of inadvertent substitution of biological products that the agency hasn’t determined to be interchangeable.

The FDA also has said that its proposed biosimilar naming convention addresses safety monitoring of biological products once they’re on the market in order to make it easier to track usage of biologics in all care settings, such as outpatient, hospital and pharmacy.

The FTC staff comment suggested that the FDA’s naming convention — which it said departs from the FDA tradition — may cause doctors to mistakenly think that the products necessarily have “clinically meaningful” differences, potentially resulting in reduced price competition in biologic drug markets.

“A misperception that the drug substance in a biosimilar differs in clinically meaningful ways from that in the reference biologic could deter physicians from prescribing biosimilars, thus impeding the development of biosimilar markets and competition,” the FTC comment read. “Biosimilar competition is important because biologics are among the most promising medicines for the treatment of a variety of medical conditions for which patients have no other alternative.”

In its comment, the FTC also pointed to ways in which the naming proposal may create unnecessary costs and conflicts with efforts toward global naming harmonization. The agency’s statement also asked the FDA to reconsider its proposal and suggested options with less impact on competition that could help avoid inadvertent substitution and improve the reporting of adverse events involving biologics.



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