Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4FDA generally expects that applications for proposed biosimilar biological products will include an assessment of immunogenicity.
single biological product licensed under section 351(a) of the PHS Act; U.S.-licensed reference product used for comparative analytical assessment; analytical studies that demonstrate that the proposed product is highly similar to the reference product
Products licensed under section 351(k) of the PHS Act
Guidance focuses on these products for interchangeability demonstrations
Stakeholders
2HCPs who make evidence-based decisions on medicinal product use.; HCPs to be educated about study participation for their patients.
Guidance for Industry
Regulatory Context
Regulatory Activities
2Biologics license application submitted under section 351(k) of the PHS Act
Submission process applicable to optical imaging drugs.
Attributes
4determination of biosimilarity includes a rigorous and comprehensive comparison of physicochemical and biological functional attributes.
Measurement of potency for biological products
specifications for the purity, strength, and composition of dietary supplements
characterizing the safety of individual drugs
Technical Details
Testing Methods
2model in vivo functional effects with a high degree of specificity and sensitivity using in vitro biological and biochemical assays.
Agency recommended that applications seeking a determination of interchangeability include data from a switching study.
Processes
1Studies intended to support a demonstration of interchangeability
Clinical Concepts
1Assessment of the immune response to the biological product
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- E11A Pediatric Extrapolation
- M15 General Principles for Model-Informed Drug Development
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Rare Diseases: Considerations for the Development of Drugs and Biological Products
- Q3C Impurities: Residual Solvents_2011
- Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry
- Q4B Annex 5: Disintegration Test General Chapter