European medicines agency guideline for biological medicinal products: a further step for a safe use of biosimilars.

Giorgio Walter Canonica,Carlo Agostini,Enrico Maggi

doi:10.1186/s12948-015-0010-3

Abstract

European medicines agency guideline for biological medicinal products: a further step for a safe use of biosimilars.

Highlights

It is sufficient to consider how changes in the cell line that produce the monoclonal antibody and/or post translational modifications, including glycosylation patterns, could alter the specificity of the target antigen binding and the effector functions of the new biosimilar
* Correspondence: carlo.agostini@unipd.it 1Department of Medicine, University of Padua, Padua, Italy Full list of author information is available at the end of the article national health systems that are at risk of being drained by the constant increase in the cost of the many biologic drugs that every year are introduced in the clinical practice
For a biosimilar that enter the process of marketing authorization, the EMA guideline recommends a stepwise conduct of non-clinical and clinical studies and dictates a number of crucial steps to be followed before authorization, including the use of pharmacodynamic and pharmacokinetic studies, clinical trials of appropriate patient populations, the choice of clinical endpoints in efficacy trials, the development of clinical safety studies, an evaluation of the immunogenicity of the biosimilar, and pharmacovigilance studies aimed at extrapolate safety and efficacy of the new biosimilar with respect to the already authorized branded medicinal product

Summary

Introduction

It is sufficient to consider how changes in the cell line that produce the monoclonal antibody and/or post translational modifications, including glycosylation patterns, could alter the specificity of the target antigen binding and the effector functions of the new biosimilar. * Correspondence: carlo.agostini@unipd.it 1Department of Medicine, University of Padua, Padua, Italy Full list of author information is available at the end of the article national health systems that are at risk of being drained by the constant increase in the cost of the many biologic drugs that every year are introduced in the clinical practice.

Results

Conclusion