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# FDA Only Wants 2 or 3 Suffixes for Biologic/Biosimilar Naming
- URL: https://www.fdaweb.com/fda-only-wants-2-or-3-suffixes-for-biologic-biosimilar-naming/
- Published: 2016-06-30T12:00:00.000Z
- Updated: 2026-09-14T21:12:41.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136094

It appears FDA made a mistake in a 6/2-published *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-12885.pdf?ref=fdaweb.com) that sought Office of Management and Budget approval on an information request outlined in a 2015 draft guidance on *Nonproprietary Naming of Biological Products* that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the nonproprietary name on such products ([see story](http://fdaweb.com/login.php?sa=v&aid=D5133146&searchWords=suffix&cate=S&stid=%241%24gr3.pK%2F.%24ghRV6oK.49zSY8T22U2lq0&ref=fdaweb.com)). When the OMB notice was submitted, the agency said it was seeking up to 10 proposed suffixes to review. However, the original guidance [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987?ref=fdaweb.com) noted that the agency was seeking up to three suffixes. It also recommended including supporting analyses demonstrating that the proposed suffixes meet the factors described in the guidance for FDA’s consideration. During a CDER update session at the Drug Information Association’s annual meeting 6/30, associate director for therapeutic biologics **Leah Christl** clarified that the agency is still looking for two to three suffixes.

Presumably because of this mistake, the OMB notice was officially [withdrawn ](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-14722.pdf?ref=fdaweb.com)on 6/21\. OMB approval was the next step in the guidance process, and the FDA withdrawal came as a surprise. An FDA spokesman told ***FDA Webview* earlier this month** that final guidance is “forthcoming,” but no specifics on the timing were provided. Now, the spokesman says that the “publication of the notice was an administrative error. FDA continues to review comments and work on a final guidance.”