U.S. Agencies Disagree On Biosimilar Naming

FDA should reconsider its proposal for naming biosimilars—generic-like versions of biologic drugs—because it could hinder competition and keep prices high, the Federal Trade Commission says. Under FDA’s proposal, each biologic drug would have a common name and any biosimilar version would adopt the common name followed by a unique four-letter suffix. FTC, a consumer watchdog agency, says that FDA’s proposal “may cause physicians to believe mistakenly that the products necessarily have clinically meaningful differences, potentially resulting in reduced price competition.” The purpose of the proposed naming convention is to improve postmarket drug safety and minimize inadvertent substitution of biologicals that FDA has not determined to be interchangeable, the drug safety agency says. The first U.S. biosimilar was marketed in September, but in the European Union, more than 20 biosimilars have been approved since 2006. An example from the EU suggests that “biosimilars with distinct nonproprietary names are less commercially successful than biosimilars with the same nonproprietary name as the reference biologic,” FTC says.