FTC Criticizes FDA’s Proposed Biosimilar Naming Rules

Biosimilar News

FDA recently proposed a new biosimilar naming convention, whereby the nonproprietary name for a biological product would require a new, random four-letter suffix.  The new naming convention is in the spirit of emphasizing that biosimilars, unlike generic drugs, are not replicas of their biologic counterpart.

In its response to the FDA’s request for comment on the proposed rules, the FTC criticized the proposed rules stating that they may confuse doctors and prevent them from prescribing biosimilars.  Specifically, if doctors believe that there are clinically meaningful distinctions in the active ingredients of the biologic and the biosimilar, they will be less inclined to prescribe the biosimilar.  The reduction of prescriptions of cheaper biosimilars could hurt competition in the biologic drug market.

To minimize this effect, the FTC suggests that the “FDA [should] consider pursuing physician education programs and testing how prescribers will react to its proposed nomenclature changes before implementing them.”  The FTC even recommends that the FDA explore alternative methods, like the use of trade names.

Stay tuned to the Big Molecule Watch for additional developments on this issue.

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