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Updated: Apr 26, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
How to compare biologic drugs
Xavier Calvet1, Juan Vicente Esplugues2,
1Servicio de Aparato Digestivo, Corporació Sanitària Universitària Parc Taulí, Universitat Autònoma de Barcelona, Sabadell, España; CIBERehd, Madrid, España.
Abstract:
This consensus document reviews the evidence on the evaluation of biological drugs. The main conclusions of the group are: a) the current evidence on biological comparisons is based on indirect comparisons and is generally unreliable and with important methodological limitations. Therefore, b) it is considered necessary to amend the regulatory directives in the sense of strongly favoring randomized non-inferiority studies comparing face to face the new biological treatment with current standards, avoiding trials versus placebo, c) A key element in this process will be determined by consensus among regulatory agencies, scientific societies, the pharmaceutical industry and health authorities regarding the clinical differences that should be considered relevant in each of the conditions tested.
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