Compliance Management

FDA Issues Biosimilar Naming Guidance

Source: FDA

Aug 28, 2015

The FDA has released a draft guidance that details the agency's proposal on the nonproprietary naming of biological products.

The guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names) that share a core drug substance name and, in order to better identify each product, a four-letter FDA-designated suffix that is unique for each product. For example, the nonproprietary name of a reference product could be replicamab-cznm, and a biosimilar to that product could be replicamab-hixf.

The proposed naming convention seeks to prevent inadvertent substitution of biological products that are not determined to be interchangeable by the FDA and to support safety monitoring of all biological products after they are on the market, by making it easier to accurately track usage of biological products.

Read the FDA blog here