Journal of Bioequivalence & Bioavailability

EU biosimilar regulations: An analysis of the data which has underpinned the approval of biosimilars granted marketing authorizations in Europe

International Conference and Exhibiton on Pharmaceutical Regulatory Affairs

6-7 September 2011 Baltimore, USA

Gary Walsh

Scientific Tracks Abstracts: JBB

Abstract:

T he European Union has enacted a comprehensive legislative framework and associated regulatory provisions for the approval of biosimilar products. Th is has underpinned the approval in Europe of 14 such biosimilars since 2006. EU biosimilar regulations require the generation of comparative data between the proposed biosimilar product and its chosen reference product, i.e. the product to which it claims biosimilarity. Th e marketing authorization application for a biosimilar product must contain a full quality module as well as reduced clinical and non-clinical data modules. Th is presentation will provide an analysis of the main datasets (quality, non clinical & clinical) that underpinned regulatory approval of several biosimilars. Th e analysis seeks to illustrate key concepts enshrined in EU biosimilar regulations and to illustrate how European regulators are interpreting those concepts in practice.

Biography :

Gary Walsh is an associate professor of biotechnology at the University of Limerick, Ireland. His research interests span various aspects of pharmaceutical biotechnology and his 220 publications include 9 authored books, 2 edited books, 12 book chapters and 70 journal articles. He has presented invited/keynote papers at 36 international conferences. He has served as editor, biotechnology section, of the European Journal of Pharmaceutics and Biopharmaceutics and as a member of the editorial boards of Biopharm. International, New Drugs and the Encyclopaedia of Industrial Biotechnology. He is a former scienti fi c secretary and member of the board of governors of the European Association of Pharmaceutical Biotechnology