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Updated: Apr 20, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Contribution of animal studies to evaluate the similarity of biosimilars to reference products
Peter J K van Meer1, Hans C Ebbers2, Marlous Kooijman3
1Utrecht Institute of Pharmaceutical Sciences, Department of pharmaceutics, Utrecht University, Universiteitsweg 99, 3584 CG Utrech, The Netherlands; Medicines Evaluation Board, Graadt van Roggenweg 500, 3531 AH Utrecht, The Netherlands.
Abstract:
The European Union (EU) was the first region to establish a regulatory framework for biosimilars, in which animal studies are required to confirm similarity to a reference product. However, animal studies described in European public assessment reports (EPARs) or marketing authorization applications (MAAs) did not identify clinically or toxicologically relevant differences despite differences in quality, suggesting that animal studies lack the sensitivity to confirm biosimilarity. Scientific advice provided learning opportunities to evolve existing guidance. Altogether, the data support a step-wise approach to develop biosimilars that focuses on quality and clinical efficacy of biosimilar. This approach might be more effective and does not necessarily require animal studies, which is also reflected in new EU draft guidance.
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