FDA plans for naming of biosimilars to balance competition and safety

“We're at a critical point for the future of biosimilars in the US. Millions of American patients stand to benefit from increased utilization of these lower-cost, high-quality products,” US Food and Drug Commissioner Scott Gottlieb declared on Thursday.

Since the biosimilar pathway was established in 2010, there has been debate about how biological products should be named, and whether a unique identifier such as a distinguishing suffix should be added to the proper (ie, non-proprietary) names of biological products to help ensure strong pharmacovigilance.

Some have argued that the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition. The FDA strongly believes in the ability of biosimilars to promote competition, lower prices and foster greater access, and is fully committed to the suite of announced and upcoming policies to help advance the goal of a robust, high-quality, competitive market for biosimilar products.