Antibody biosimilars: fears or opportunities?

Le 28 mai 2013, Vinci Centre International de Congrès de Tours

8h30-9h: Welcome

9h-9h30: Introduction

9h30-11h: 1st session - Market and regulatory issues

Brief overview of the IP landscape in the medical field. When do (Biotech) patents actually expire? Of SPCs, PEs and PTEs
André Bourgouin, Partner, Grosset-Fournier & Demachy, Paris, France

Regulatory perspective on biosimilar in the EU
Kowid Ho, ANSM, Department for evaluation of biological products, France

Challenges to Develop and Implement a Manufacturing Process for Biosimilars
Steve Flatman, Head of Biosimilars R&D at Lonza, UK

11h-11h30: Coffee break

11h30-13h: 2nd Session - Quality control attributes, bioequivalence and formulation

Acceptable changes in quality attributes of antibodies and assimilated biopharmaceuticals
Hansjörg Toll, Analytical Characterization group, Sandoz Biopharmaceuticals, Kundl, Austria

Myths and Facts around Consistent Quality of Biotech Products
John Stults, Director of the Protein Analytical Chemistry Department, Genentech, USA

Functional in vitro assays for evaluating the Fc function of therapeutic monoclonal antibodies: issues and proposed strategies
Chritian Behrens, LFB Biotechnologies, Les Ulis, France

13h-14h30: Lunch

14h30-16h: 3rd session - Development of biosimilars

EU clinical requirements
Marie-Christine Bielsky, Medicines and Healthcare products Regulatory Agency, London, UK

Clinical evaluation of Remsima®, an infliximab biosimilar
Dae Hyun Yoo, Department of Internal Medicine, Hospital for rheumatic Diseases, Hanyang University, South Korea

Indication extrapolation for biosimilar monoclonal antibodies
Valentine Sallerin, Global Medical Affairs, AbbVie Pharmaceuticals, France

16h-16h30: Coffee break

16h30-17h30: 4th session - Societal issues

Pressure on the Health Economy - why we need Biosimilars
Paul Greenland, Vice President Biologics, Hospira UK

Ethical issues about clinical evaluation of biosimilars
Emmanuel Gyan, CHRU and Université François-Rabelais de Tours, France