Wolfgang A. Rehmann
Taylor Wessing, Germany
Title: Biosimilars in Europe – the role of EMA's guidelines
Biography
Biography: Wolfgang A. Rehmann
Abstract
In Europe biosimilars are governed by the statutory provisions applicable for generic medicines. The legal requirements and the procedures for making an application for a marketing authorisation are set out in Directive 2001/83/EC and in Regulation (EC) No 726/2004. There are a number of possible approaches to getting approval for a biosimilar product in Europe, in particular to either submit a full dossier of pre-clinical and clinical data as would be required for any new medicinal product or to apply under the abridged procedure. An applicant for approval of a biosimilar product under the abridged procedure is required to demonstrate that its product is similar to a previously authorised product. The EMA is responsible for assessing applications from companies to market biological medicines for use in the European Union, including biosimilar medicines in case the centralised procedure is applicable. The EMA has published guidelines that govern how biosimilars are to be assessed. There are three guidelines that apply to all biosimilars: an overarching guideline which was first adopted in September 2005 and was amended in 2014, coming into effect on 30 April 2015; and two further guidelines which were both adopted by the EMA on 22 February 2006, one relating to non-clinical and clinical issues and one to quality issues. The guideline on quality issues was also amended in 2014. The presentation will give an overview to the audience about how the legal framework in the EU works and will give an update on most recent legal development within the EU in this regard.