FDA Releases Guidance on Biosimilar Naming

August 28, 2015
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

Pharmaceutical Executive

August 28, 2015.

The long-awaited draft guidance on biosimilar naming has been posted by FDA, reports BioPharm International's Randi Hernandez.

Within the document, the agency suggests naming follow-on biologics by a common nonproprietary name, followed by a suffix that will identify the manufacturer of the particular biosimilar. The naming scheme is consistent with the way the agency labeled Zarxio (filgrastim-sndz), the first biosimilar product to be approved by FDA. The naming convention will be used for all future biosimilar products and will also be applied retroactively, meaning the naming convention will apply to biologic products that are already on the market.

For more on this story, read the BioPharm International report here.