Consumer and Taxpayer Letter to FDA on Proposed Suffix for the Proper Name of a Biological Product
May 2, 2019
Seven groups express concern over FDA's newly released guidelines onbio similar naming
According to the letter, "biologic drugs are the biggest driver of rising drug prices in the United States, and represent nearly all net spending growth on prescription drugs since 2014. Adding a unique naming system, which would impede interchangeability, could keep costs high due to lack of competition, even after the 12-year patent protection period has expired. We urge the FDA to set aside these new guidelines in favor of the internationally recognized, pro-consumer and pro-patient norm, and instead renew the agency’s efforts to bring new biosimilar drugs deemed safe and effective to market as quickly as possible."