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General Notices and Requirements Biologics Nomenclature

Type of Posting: General Announcement
Posting Date: 09–Jun–2022

On June 1, 2022, USP published as approved an update to the General Notices and Requirements Section 2.20 Official Articles. The revision becomes official December 1, 2022. This revision was initially proposed in 2017 after the U.S. Food and Drug Administration’s (FDA) issuance of its final guidance, Nonproprietary Naming of Biological Products in January 2017. Comments on the initial proposal can be found here. The final guidance indicated FDA’s thinking that biological products licensed under the Public Health Service Act (PHS Act) bear a nonproprietary name that includes an FDA-designated suffix. This guidance also referenced FDA’s intent to continue its practice of designating the names of biological products with a prefix, where necessary. In 2019, FDA issued an additional draft guidance document, Nonproprietary Naming of Biological Products: Update
To understand the impact of this revision, USP has held ongoing scientific engagements, conducted an additional publication for comment in Pharmacopeial Forum, and hosted a stakeholder roundtable. The proposal received varied stakeholder comments  expressing both support and opposition. 

Given that the naming convention for biological products has not been the subject of recent FDA developments, the USP Council of Experts (the CoE) decided to move forward at this time with this revision to become official. The CoE determined the revision is necessary to clarify the continued applicability of USP public quality standards to biological products and to prevent confusion and potential compliance issues for industry.
The purpose of this revision is to clarify the continued application of USP public quality standards to biologic products that may be assigned an FDA-designated prefix and/or suffix, including originator biological products, related biological products, biosimilar products, and interchangeable products and is not intended to comment on FDA’s biological product naming policy. This revision will help provide clarity to stakeholders with respect to FDA’s naming convention and official titles of USP monograph standards.  

Questions may be directed to Fouad Atouf, Vice President, Global Biologics (