From the biosimilar concept to the marketing authorisation

Abstract

The « standard » generic approach, that requires for a chemical substance a simple demonstration of bio-equivalence with the reference product is not adequate to evidence a biosimilar's quality, safety and efficacy, due to the complexity of the products themselves but also of their production processes. The registration of biological products' copies has been made possible by the creation of a specific regulatory framework by European regulatory authorities, This framework is referred to as « biosimilar approach ». In this chapter are described the general framework of registration and applications specific to onco-hematology field, through the examples of rG-CSF and EPO