Biosimilars in the EU: Nonclinical and Early Clinical Development

Abstract

This article provides a summary of the regulatory pathway that exists in the European Union for the development of biosimilars. An overview of the current regulatory framework, applicable guidelines, and key stakeholders in the EU regulatory environment for biosimilars is discussed, as well as benchmark information through case studies on the need for comparability nonclinical and clinical studies conducted before registration. Discussion on immunogenicity and pharmacokinetic and pharmacodynamic comparisons of products approved will provide guidance for the next generation of biosimilars in Europe. The discussion is based on the experience of the authors.