Description
This guidance describes FDA’s current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear anonproprietary name2that includes an FDA-designated suffix. Under this naming convention, the nonproprietary name designated for eachoriginator biological product,related biological product, andbiosimilar productwill be a proper name that is a combination of thecore nameand a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.The suffix format described in this guidance
Scope & Applicability
Product Classes
6Requires analytical comparability per ICH Q5E
biological products shown to be biosimilar to a reference product
licensed under section 351(a) of the PHS Act; Biological products licensed under section 351(a) of the PHS Act; Biological product submitted in a stand-alone BLA under section 351(a)
Biosimilar product determined to be interchangeable with the reference product
Biological products that meet the definition of a device
Biological product submitted in a BLA under section 351(a) with a previously licensed drug substance
Stakeholders
3ensure information is clear and accessible to HCPs
Entity expected to have control over manufacturing for biological products
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
4Drug name not protected by trademark
Requirement for the four-letter suffix
Naming format for biological products in the combination regimen.
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)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)
- Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (Status: Draft)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- Nonproprietary Naming of Biological Products: Update Guidance for Industry (Status: Draft)
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry (Status: Final)
- Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (Status: Final)