FDA releases final guidance on biosimilar naming

January 13, 2017 7:36 PM


The U.S. Food and Drug Administration (FDA) released its final guidance for industry on the “Nonproprietary Naming of Biological Products” yesterday.

The guidance describes FDA’s current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix.  Under this naming convention, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.

The suffix format described in this guidance is applicable to originator biological products, related biological products, and biosimilar products previously licensed and newly licensed under section 351(a) or 351(k) of the PHS Act.  FDA is still continuing to consider the appropriate suffix format for interchangeable products.

According to the FDA, distinguishable nonproprietary names will also facilitate accurate identification of these biological products by health care practitioners and patients.  Further, distinguishing suffixes should help minimize inadvertent substitution of any such products that have not been determined to be interchangeable.

The guidance can be found on FDA’s homepage and can also be accessed from here.


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