Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway

Chamberlain P. Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway. Biosimilars. 2014;4:23-43

Abstract

Clinical evaluation of comparative immunogenicity represents an important component of the European Union regulatory review process for candidate biosimilar products. The clinical evaluation is part of a multidisciplinary review that cross-refers to product quality attributes as well as preclinical and ongoing risk management considerations. Results from the monitoring of anti-drug antibody formation in relevant populations treated for an adequate period of time are interpreted in relation to clinically relevant endpoints, including pharmacokinetics, pharmacodynamics, efficacy, and safety parameters. The experience gained during the 10-year period following the implementation of the European Union biosimilars pathway indicates that a suitably cautious approach was applied, insofar as no immunogenicity-related issues have emerged for the approved applications of the different biosimilar products.

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Cell-Based Assays

Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

Pharmacokinetics & Pharmacodynamics (PK/PD)

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

Case Studies

Learn why we’re a trusted partner to 22 of the top 25 global pharma and biotech companies.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.

SPEAK TO A SCIENTIST
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