Fact Sheet

Biosimilars Naming

PhRMA December 1, 2015

Naming for biologics and biosimilars remains an outstanding issue on which the U.S. Food and Drug Administration (FDA) must finalize regulations. The FDA has issued a draft guidance on nonproprietary naming for biologic medicines, proposing that all original biologic medicines and biosimilars share a core, nonproprietary name that is accompanied by a unique suffix to distinguish them from one another for prescribing and administration. PhRMA supports the proposal for distinguishable nonproprietary names for biologics, but recommends that suffixes be unique to the license holder, generally derived from the company’s name and generally shared across all of the license holder’s biological products.