Description
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Nonproprietary Naming of Biological Products: Update.” This draft guidance describes FDA's current thinking on nonproprietary names of biological products licensed under the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish the objectives of the naming convention described in the final guidance for industry, “Nonproprietary Naming of Biological Products,” dated January 2017. Similarly, FDA does not intend to apply the naming convention described in the final guidance for industry, “Nonproprietary Naming of Biological Products,” to biological products that are the subject of an approved application under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under the PHS Act (transition biological products). FDA is also reconsidering whether vaccines should be within the scope of the naming convention. In addition, the draft guidance describes FDA's current thinking on the appropriate suffix format for the nonproprietary name of an interchangeable biological product licensed under the PHS Act. Based on the comments received in the docket, we intend to revise the final guidance, “Nonproprietary Naming of Biological Products,” dated January 2017 and to amend sections in that document regarding the subjects addressed in this draft guidance.
Scope & Applicability
Product Classes
8A biological product subject to an approved application under section 505 of the FD&C Act transitioning to a BLA
The biological product to which a biosimilar is compared
Preventative or therapeutic vaccines for infectious diseases.
Guidance on immunogenicity assessment and testing
Products for which batch/lot information is particularly important
products approved under section 505 of the FD&C Act deemed to be BLAs
biological products shown to be biosimilar to a reference product
Biosimilar product determined to be interchangeable with the reference product
Stakeholders
2Physicians, veterinarians, dentists, and other licensed professionals
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2distinguishing four lowercase letter addition to the core name
component of the proper name
Related CFR Sections (1)
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
Related Warning Letters (1)
- 2024-10-15
CGMP/Blood & Blood Components/Adulterated
Hemarus LLC
See Also (8)
- Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for Industry (Status: Final)
- Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry (Status: Final)
- Nonproprietary Naming of Biological Products Guidance for Industry (Status: Final)
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry (Status: Final)
- Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
- Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products (Status: Draft)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)