FDA Releases Biosimilar Naming Guidance

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.”  The guidance provides that naming for originator biological products, related biological products, and biosimilars should include a “core name” followed by a four-letter suffix.  The core name typically will be the USAN Council name for the Reference Product (RP).  The suffix should be four lowercase letters, with no numerals, that is both unique and “devoid of meaning.”  The new naming convention will apply to both newly-licensed and previously licensed biological products, although FDA is still considering how to implement the new naming convention for previously licensed products.  As with FDA’s prior naming proposal, FDA’s final guidance conflicts with prior recommendations from WHO to provide different “Biological Qualifiers” for the RP and biosimilars, including a numeric “checksum,” that are separate from the nonproprietary name.

Today, FDA also released its guidance agenda, which details new and revised draft guidances that CDER will publish in the coming year.  Relevant to biosimilars, FDA has stated that it will release two guidances:  “Considerations in Demonstrating Interchangeability with a Reference Product” and “Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity.”