Wolfgang A. Rehmann

Diana Heimhalt

Partner Lifesciences
Taylor Wessing Partnergesellschaft
Munich, Germany

Abstract

As a number of biological medicinal products come off patent by 2020 biosimilars are in the focus with regard to new market launches. Three guidelines published by the EMA supplemented by a number of product or class specific guidelines are designed to help preparing the documentation needed in the authorisation process. The article is addressing the function and content of the respective guidelines and also gives some comparative overview with regard to the respective FDA´s guidelines.

INTRODUCTION
There is likely to be an increasing focus on biosimilars over the next few years as an estimated $100 billion-worth of biological medicinal products will come off patent by 2020. Even if there is no formal definition of biosimilar in European legislation, biosimilars are commonly understood as biological medicinal products that are similar to another biological product that has already been authorized and which do not differ significantly from the original products in terms of quality, safety, and efficacy. As such, biosimilars are reproductions of biological medicines that are already approved. Biological medicines are medicines that are made by living organisms, such as a bacterium or yeast. The use of the term “similar” reflects the scientific reality that biological products cannot be copied precisely and therefore are reproductions rather than pure copies.

LEGISLATIVE APPROACH IN EUROPE
In principle, in Europe biosimilars are governed by the statutory provisions applicable for generic medicines. According to Article 10(2) of Directive 2001/83/EC on the Community code relating to medicinal products fo ...