FDA’s New Draft Biologic Naming Guidance


On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current thinking on biological products licensed under Section 351 of the Public Health Service Act (“PHS Act”). This draft guidance serves as an update to FDA’s January 2017 guidance document in which it considered using a distinguishing suffix to the proper names of both originator and biosimilar biological products. The 2017 guidance also stated that the FDA was considering retrospectively changing the names of biological products already on the market to add a distinguishing suffix to the proper names.

FDA Commissioner Scott Gottlieb stated that FDA no longer intends to modify proper names of biological products that have been licensed or approved under the PHS Act without an FDA-designated suffix and does not intend to apply this naming convention to transition biological products. The Naming Guidance states that,

“FDA has determined that the core objectives of the naming convention — pharmacovigilance and safe use — can be accomplished by applying the naming convention to biological products at the time they are licensed under section 351 of the PHS Act, and without applying it to licensed biological products that do not contain a suffix in their proper names.”

According to the Naming Guidance, FDA intends to designate a nonproprietary name that is a combination of the core name and a distinguishing suffix that is devoid of any meaning to all biological products at the time they are licensed under 351(a) or 351(k) of the PHS Act. The Naming Guidance states that an applicant for a proposed interchangeable product should submit up to 10 proposed suffixes in the order of the applicant’s preference, along with any supporting analyses of the proposed suffixes.

Commissioner Gottlieb, who announced last week his plan to resign from the agency, said “[b]ased on the comments received for today’s draft guidance, we intend to ultimately issue a revised, final version of the 2017 Nonproprietary Naming of Biological Products guidance that amends the relevant sections necessary to incorporate input we receive through this comment period.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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