Designation of Official Names and Proper Names for Certain Biological Products

A Proposed Rule by the Food and Drug Administration

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official names and proper names for certain biological products, following the naming convention outlined in the draft guidance Nonproprietary Naming of Biological Products.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.

Current Name Biologics License Application Proposed Official Name/Proper Name
filgrastim 103353 filgrastim-jcwp
filgrastim-sndz 125553 filgrastim-bflm
tbo-filgrastim 125294 filgrastim-vkzt
pegfilgrastim 125031 pegfilgrastim-ljfd
epoetin alfa 103234 epoetin alfa-cgkn
infliximab 103772 infliximab-hjmt