Paya Serai Coffee House 1st National Bio-Therapeutics Congress - Putting Patient First 22 November 2014 at PJ Hilton General Agenda Start End Topic Speaker Venue 0830 0900 Registration of delegates NA Ballroom Foyer 0910 Welcome address Mr Yew Wei Tarng President, PhAMA Ballroom 0930 Opening Remarks Y. Bhg. Dato Eisah A Rahman Senior Director of Pharmacy Services Ministry of Health 1015 Evolving Regulatory Landscape & Challenges in Evaluating Biosimilars Pn. Arpah Abas Deputy Director/ Head of Biotechnology Section, National Pharmaceutical Control Bureau 1030 Coffee Break 1130 Size does Matter ? Professor João Eurico da Fonseca Head of the Rheumatology Research Unit at the Instituto de Medicina Molecular and Professor of Rheumatology and Biomedical Engineering, both part of the Faculty of Medicine, University of Lisbon, Portugal. 1215 Regulating the development and approval of biosimilar monoclonal antibodies – Considerations on some Regulatory and Clinical Topics Dr. Thomas Schreitmueller Head, Regulatory Policy, Biologics, Roche 1315 Lunch Paya Serai Coffee House 1415 Case presentation Indication extrapolation Interchangeability and substitution Biologic Qualifier – An INN proposal By: Dr. Paul Cornes, Consultant Clinical Oncologist, UK 1435 Launch of PhAMA Biosimilars Position paper Ms Leah Goodman 1st Vice-President of PhAMA 1450 1620 Breakout session & Panel Discussion See overleaf for sessions Anggerik 1 & Anggerik 2 (Second Floor) 1635 Wrap up of full day MC 1650 Closing Mr. Muru Annamalai 2nd Vice-President of PhAMA

Anggerik 1 & Anggerik 2 (Second Floor) Workshop sessions Session Speaker Topic Venue Workshop 1 Professor João Eurico da Fonseca Head of the Rheumatology Research Unit at the Instituto de Medicina Molecular and Professor of Rheumatology and Biomedical Engineering, both part of the Faculty of Medicine, University of Lisbon, Portugal. A Physician's Consideration towards Bio similars (Rheumatologist ,Gastroenterologist and Dermatologist) An interactive 1 – 1 session with physicians across the discipline to understand the common challenges ,unmet needs and factors that influence a physicians mind when deciding between an innovator biologic and a bio similar compound Anggerik 1 & Anggerik 2 (Second Floor) Workshop 2 Speaker 1: Dr. Paul Cornes Consultant Clinical Oncologist, UK Speaker 2: Dr. Paul Cornes Speaker 3: Dr. Thomas Schreitmueller Head, Regulatory Policy Biologics, Roche   20 mins: Globalization of Biosimilars 20 mins: The rising costs in healthcare - can Biosimilars help? 20 mins: The needs and challenges of Innovation in healthcare 30 mins: Q&A and comments Ballroom (First Floor)