FDA Updates Guidelines for Biosimilar Naming Convention

June 6, 2016

FDA Alters Guidelines for Naming Biosimilar Products

On August 28, 2015, FDA announced the availability of a draft guidance, entitled “Nonproprietary Naming of Biological Products,” which established a naming convention for biological products.  The proposed naming system stated that all biological products licensed under the Public Health Services (PHS) Act would be assigned a nonproprietary name consisting of a core name and distinguished suffix.  The FDA also noted that this suffix would be made up of four letters and would not be derived from the manufacturer’s name.

On Thursday, June 2nd the FDA announced its plans to alter its guidelines on the nonproprietary naming convention for biosimilar products.  In the proposed guidance, FDA states that “there is a need to clearly identify biological products to facilitate pharmacovigilance and, for the purposes of safe use, to minimize inadvertent substitution.”  The suffix will still consist of four lowercase letters that will be used as a unique identifier and will be included in the proper name designated by FDA; the suffix will also continue to be included in the nonproprietary name of the product.  However, the difference is that FDA will be asking sponsors to submit up to ten proposed suffixes, listed in the order of the sponsor’s preference.  FDA also recommends that sponsors include “supporting analyses demonstrating that the proposed suffixes meet the factors described in the guidance for FDA’s consideration.”

FDA notes that “this naming convention is applicable to biological products previously licensed and newly licensed under section 351(a) or 351(k) of the PHS Act (42 U.S.C. 262(a) or 262(k)).”  FDA is asking interested persons to submit comments by Tuesday, July 5th.  For additional information, view the FDA’s notice in the Federal Register.

Do you have a biosimilar or other FDA-regulated product in development?  We can help you obtain FDA approval.  For more information on our services and how we can help you, contact us today.


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