FDA Reiterates Proposed Naming Conventions for Biosimilars

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-07-2016 13:06


The US Food and Drug Administration (FDA) has re-iterated its position to include suffixes in its naming conventions for biosimilars and follow-on biologics. In a Federal Register notice on June 2, 2016, the agency outlined its current position on the naming convention as well as summarized the comments it had received from its draft guidance, Guidance for Industry on Nonproprietary Naming of Biological Products.That draft guidance, issued in August 2015, describes FDA's current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a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. The FDA said that there "is a need to clearly identify biological products to facilitate pharmacovigilance and, for the purposes of safe use, to minimize inadvertent substitution. Accordingly, for biological products licensed under the PHS Act, FDA intends to designate a nonproprietary name that includes a core name and a distinguishing suffix." 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)).

The guidance includes information collection by requesting that 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 PHS Act. The suffix will be incorporated in the nonproprietary name of the product. The guidance recommends that applicants should submit up to 10 proposed suffixes, in the order of the applicant's preference. The FDA also recommend including supporting analyses demonstrating that the proposed suffixes meet the factors described in the guidance for FDA's consideration.

The FDA said that most comments supported its proposal to designate a suffix. Many comments suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products. Some comments supported use of a random suffix to avoid creating an unfair advantage for specific manufacturers. Several comments stated that the current practices of FDA and non-FDA entities for identifying biosimilar and interchangeable products is sufficient for the purpose of pharmacovigilance, and designation of a suffix is not needed.

. One comment stated that FDA's estimate of six hours to submit proposed suffixes is based only on the time needed to prepare the submission itself after the multiple suffixes have been selected. The comment further stated that because the FDA suggests that each respondent submit three suggested suffixes for consideration, the time needed to do an analysis of each suffix would exceed 720 hours per suffix (based on their own company experience) or 2,160 hours total for the three suffixes.

In response, the FDA estimated that sponsors would spend two hours completing the submission for each of the three suffixes, resulting in six hours as the average burden. This estimate is an annualized figure based on the average number of responses per respondent and the average burden per response over a three-year period.

Source: Federal Register


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