FDA Announced Final Guidance on “Nonproprietary Naming of Biological Products”
The FDA announced the release of the final guidance on the “Nonproprietary Naming of Biological Products.” The agency has decided on a naming convention that supports a distinguishable randomized, four-letter suffix, devoid of any meaning for biosimilars. However, the FDA is still continuing to consider the appropriate suffix format for interchangeable biological products. Please select the button below for the full guidance.
The Federal Register alert mentions the open comment period; exact dates are not set yet, but would likely be February 13.
Read the Full Report