Correspondence: Elisabeth Berthet-Maillols, Armengaud & Guerlain, 12, Avenue Victor Hugo, Paris 75116, France. E-mail: eberthet@wanadoo.fr

¹is a doctor of Pharmacy, a doctor of Law, and, since 2000, a lawyer before the Paris Bar. She works for the Paris law firm Armengaud & Guerlain, where she specialises in industrial property and pharmaceutical law. Before becoming a lawyer, she worked from 1993 to 1999 with European Patent Attorneys. She is the author of the book 'Les obstacles juridiques à l'essor des génériques' ('Legal obstacles to the growth of generics'; 1999, Editions de la santé). She has also published papers for many years and lectured on legal and regulatory issues resulting from competition between generics/biosimilars and their princeps.

Received 9 January 2009; Revised 9 January 2009.

Abstract

The arrival of biosimilar medicinal products on the market has given rise over the past few years to numerous questions, especially concerning their safety. Although generics have now acquired legitimacy, biosimilars don't yet benefit from full confidence. However, one shouldn't compare that which isn't comparable; the generics of chemical medicines have nothing to do with the biosimilars of biotechnology medicines. Specifically, biosimilars of erythropoietin seem to be viewed with a certain fear due to the secondary effects that occurred with the reference product Eprex^®. The aim of this paper is to show that the regulatory framework implemented at the European level around these products allows us to be confident as to their efficacy and their safety.