On October 28, 2015, the Federal Trade Commission (FTC) submitted a comment to the U.S. Food and Drug Administration’s (FDA) draft guidance addressing nonproprietary names for biosimilar drug products.1
In the draft guidance, the FDA proposed to require that each biological product licensed under the Public Health Service Act bear a nonproprietary name that includes a “unique FDA-designated suffix,” in order to improve pharmacovigilance and to help minimize inadvertent substitution of biological products that the FDA has not determined to be interchangeable.2 The FDA would require that the proposed suffix be unique and devoid of meaning, and not make any misrepresentation with respect to safety or efficacy.3 In addition, the suffix should not include abbreviations commonly used in clinical practice so as to be misinterpreted as another element on the prescription order.4 The guidance specifically requires that the suffix should not “look similar or . . . be mistaken for the name of a currently marketed product” so as to reduce the risk of confusion or medical errors with the product and/or other products in the clinical setting.5 Thus, under the FDA proposal, a biosimilar and each of its reference biologics would have different suffixes.
The FTC however, cites a concern that the “FDA’s proposal – to assign different suffixes to the drug substance names of biosimilars and their reference biologics – could result in physicians incorrectly believing that biosimilars’ drug substances differ in clinically meaningful ways from their reference biologics’ drug substances.” According to the FTC, this misperception that the drug substance in a biosimilar differs in a clinically meaningful way from that in the reference biologic could deter physicians from prescribing biosimilars, thus impeding the development of biosimilar markets and competition.6
As alternatives to the agency’s proposed “unique FDA-designated suffix,” the FTC suggests simply relying on trade names to identify the manufacturer of a product, and confirm that such a product has been determined to be interchangeable.7 Similarly, the FTC argues that consultation of the Purple Book can prevent inadvertent substitutions by pharmacists simply following the established generic-for-brand substitution that has worked for decades for small molecule prescription drugs.8
While it remains to be seen if the FDA will revise its guidance for nonproprietary naming, the FTC’s rationale does not appear to address that the proposed naming convention is itself designed to promote both safety and competition.
As indicated in the FDA guidance, the use of the suffix is designed at least in part, to allow differentiation between products that meet the “biosimilar product” standard, and those that meet a higher standard so as to be considered an “interchangeable product.”9 Allowing a pharmacist or prescribing physician to differentiate between these classes of products rapidly and easily based on a designated suffix could help ensure safety of the substitute for the originator biological product. It would likely not hinder competition between the branded drug and substitutes, but rather would increase competition at the brand/generic level, as well as between the generics themselves. Companies that invested more time and money in a biologic so as to obtain the “interchangeable” designation should be able to differentiate from their competitors that chose not to do so. By allowing rapid and simple determination of these differences, the use of an FDA-designated suffix would likely increase competition between not only brands and generics, but between the generics themselves. The FTC’s comment does not appear to address these issues.
2 Food & Drug Admin., Dep’t Health & Hum. Servs., Nonproprietary Naming Of Biological Products: Guidance For Industry (2015) available at: www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/-guidances/ucm459987.pdf (hereinafter “FDA Guidance”)
3 Id. at page 10.
6 FTC Comments at page 2.
7 <span id=”seven”Id. at 14.
9 FDA Guidance at page 2.