How the European Union reviews and approves ‘follow-on biologics’ or biosimilar products

Thank you for giving me the opportunity to testify today. My name is Nicolas Rossignol. Since 2003 I have been working as an Administrator within the European Commission, in the division in charge of the European Community pharmaceutical legislation. The European Commission has three main roles in the area of pharmaceuticals: it proposes new legislation; it implements existing legislation; and it authorises and monitors the placing on the EU market of certain types of medicines, including all biotech products produced by recombinant DNA technology (e.g. insulin, growth hormones, etc.). The granting of this ‘marketing authorisation’ is done on the basis of a scientific evaluation of the product, which is carried out by the European Medicines Agency (EMEA). Since 2003 I have been responsible within the European Commission for the implementation of the EU Pharmaceutical legislation in the specific field of ‘follow-on biologics’, which we call in Europe ‘similar biological medicinal products’ or ‘biosimilars’. I have been involved in the legal, regulatory and scientific aspects of this topic. It is arguably one of the most complex issues that the European Community has faced in the area of pharmaceuticals in the last 5 years. My testimony today will focus on how the European Union reviews and approves ‘follow-on biologics’ or biosimilar products. I will address the following issues: