Designation of Official Names and Proper Names for Certain Biological Products

FDA is proposing a regulation to designate official names and proper names for certain biological products, following the naming convention outlined in the draft guidance Nonproprietary Naming of Biological Products. The current names and proposed names are shown in the table. As stated in the proposed rule, FDA is seeking action with respect to these six products because of the need to encourage routine use of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices, as well as to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.

FDA intends to update this guidance to include additional questions and answers as appropriate. The current version of the document is available on the Federal Register website.