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ProjectPageLayOutIconGuideline on Quality Considerations for Development and Comparability Assessment of Biosimilars

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    ABBREVIATIONS
    1. Executive Summary
    2. Introduction
    3. Scope and Purpose
    ​4.1 Biosimilar Quality/Chemistry Manufacturing Control data
    ​​4.2 Comparative Quality Exercise between the Reference Product and the Biosimilar
    ​4.3 Definition of the Reference Product ​
    ​4.4 Extra​polation of Indication
    Biosimilar Development Paradigm: Stepwise and Tailored Approach
    ​​5.1.1 Quality Target Product Profile
    ​​5.1.2. Drug Sub​stance of Biosimilar
    ​5.1.3. Drug Product of Biosimilar
    ​​5.1.4 Analytical Test Methods for Biosimilar
    ​5.1.5 Specification of Biosimilar
    Considerations for Comparative Quality Exercise
    ​5.2.1 Comparative Physiochemical Properties
    5.2.2 Comparative Biological Activity
    5.2.3 Comparative Purity and Impurities
    5.2.4 Comparative Quantity
    5.2.5 Comparative Stability and Degradation
    Selection and Identification of Batches of Reference Product and the Biosimilar
    5.2.6.1 Reference Product Batches
    5.2.6.2 Biosimilar Batches
    5.2.7 Use of Official Biological Product Reference Standards
    5.2.8 Analytical Method consideration
    5.2.9 Statistical Approaches
    6. Glossary
    7. Reference

Last update: 30 May 2024

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