Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars

The AAPS Journal
Kristof VandekerckhoveHenriette Kuehne

Abstract

Leading regulatory agencies recommend biosimilar assessment to proceed in a stepwise fashion, starting with a detailed analytical comparison of the structural and functional properties of the proposed biosimilar and reference product. The degree of analytical similarity determines the degree of residual uncertainty that must be addressed through downstream in vivo studies. Substantive evidence of similarity from comprehensive analytical testing may justify a targeted clinical development plan, and thus enable a shorter path to licensing. The importance of a careful design of the analytical similarity study program therefore should not be underestimated. Designing a state-of-the-art analytical similarity study meeting current regulatory requirements in regions such as the USA and EU requires a methodical approach, consisting of specific steps that far precede the work on the actual analytical study protocol. This white paper discusses scientific and methodological considerations on the process of attribute and test method selection, criticality assessment, and subsequent assignment of analytical measures to US FDA's three tiers of analytical similarity assessment. Case examples of selection of critical quality attributes and ana...Continue Reading

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Citations

May 17, 2019·The Journal of Dermatological Treatment·Jonathan BarkerTaegyun Kang
Aug 17, 2020·International Journal of Environmental Research and Public Health·Vesa HalimiAleksandra Grozdanova
Jan 18, 2021·Biologicals : Journal of the International Association of Biological Standardization·Ali M AlsamilHelga Gardarsdottir
Jun 8, 2021·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Aqsa SafdarMuhammad Zaman
Jun 19, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Christopher J WebsterGillian R Woollett
Aug 26, 2021·Expert Opinion on Biological Therapy·Anurag Rathore, Himanshu Malani

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Methods Mentioned

BETA
electrophoresis
X-ray
ELISA

Software Mentioned

Mab
Mab assessment Tool

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