Paolo Rocco

Co-author:
Paola Minghetti

Department of Pharmaceutical Sciences
Università degli Studi di Milano
Milan, Italy

Abstract

In the European Union, the regulatory policy for biosimilars has enabled different biosimilar products to be marketed, and in the USA the market for biosimilars is starting to gain momentum. In this paper, we outline the legislative framework of biosimilars in the USA and Europe, highlighting the differences with generics in terms of assessing their quality, efficacy and safety, with particular focus on the consequences on interchangeability and substitution.

INTRODUCTION
The high cost of biotechnological medicinal products and the increasing number of patent and data protection expirations has led manufacturers to develop their own version of marketed biological products. In principle, the Marketing Authorisation Application in these cases could be handled by the regulatory Agency either as a new application, with full dossier, or as an application accounting for the fact that some of the data are already known, with a simplified/hybrid dossier. In the European Union (EU) and the USA a framework of regulations and guidelines following the latter route has made these products a reality of the pharmaceutical market. As opposed to the case of generics, such products can be demonstrated to be similar, but not identical, to a previously authorised reference product, and are therefore defined “biosimilars”. Since the chemical characteristics of biological medicinal products are directly related to the manufacturing process, and cannot be duplicated exactly, biosimilars require a different approach to the Marketing Authorisation (MA), with respect to both originators and generics (1).

The aim of this ar ...