FDA Final Guidance on Nonproprietary Names of Biological Products


In January, 2017, the FDA released a final guidance document outlining its rules for giving nonproprietary names to biological products. The issue has been controversial, since unlike with a generic version of a traditional pharmaceutical that truly is chemically identical to the pioneer drug, in the biological world products may be "biosimilar" but not necessarily identical to the pioneer. Thus, while ibuprofen is the same drug whether sold under the mark ADVIL or a private label brand, biosimilar products are not necessarily exactly the same. Use of the same generic name ("proper name" in FDA-speak) for all biosimilar biologics could therefore be misleading.

To address the problem, the FDA now requires that each original biological product, related biological product, and biosimilar product include a combination of (1) a core name from the U.S Adopted Names Council (the same group that adopts generic names for pharmaceuticals) and (2) a nonproprietary lower-case four letter distinguishing suffix that is devoid of meaning. This suffix may not even connote the name of the product license holder. Thus, replicamab-hjxf is acceptable, whereas replicamab-merk is not. The FDA's rules do not preclude a proprietary name from also being used with biologics, but companies must now be aware of the rules of the road for applying different proper/generic names to their biologics prior to marketing.