The (suf)Fix is In: FDA Opens the Floor for Comments on Biologic Naming Guidance

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Regulatory Guidances  •  U.S. FDA News

Today, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure for biological products licensed under the 42 U.S.C. 262(a) or 262(k).  The proper name for each product will include the nonproprietary name of the product followed by a four letter suffix—for example, the Remicade biosimilar Inflectra (infliximab-dyyb).

The guidance recommends that applicants submit up to 10 proposed suffixes in order of preference and further recommends including supporting analyses demonstrating compliance of the proposed suffixes with the factors described in the FDA’s prior guidance on the topic.  This new proposal is a response to comments from the FDA’s August 28, 2015 notice (80 FR 52296) regarding suffixes.  Those comments primarily stressed the need for “a meaningful, distinguishable suffix [that] may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products.”

The proposed naming scheme is similar to one proposed by WHO, although the FDA’s proposed scheme differs by allowing for meaningful four-letter suffixes, contrary to the random suffixes proposed by WHO.

The new comment period remains open through July 5, 2016.

Follow Big Molecule Watch for continuing coverage on this issue.

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