1st Annual Biosimilars Forum - Statistical Methodologies in Biosimilar
The 1st Annual Biosimilars Forum was hosted in Budapest, 6-7 October, 2016 by Acclesiors Ltd.. Clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this hot topic of research in lectures and informal discussions.
The program started with Professor Shein-Chung Chow's lecture on the design and analysis of biosimilar studies, providing an overview of current FDA regulatory requirements for assessing biosimilarity of biosimilar products and giving a detailed description of the fundamental differences and assumptions between the chemical generic products and follow-on biologics. Johanna Mielke (Biostatistician, Novartis Pharma AG) provided a bigger picture through a systematic review of authorised biosimilars in the European Union. ”Biosimilars are essentially cheaper than the original drugs” – said Prof Dr László Endrényi (Professor Emeritus, University of Toronto), key lecturer of the event, thus it is not only a business opportunity for developers to put them on market, they also foster having sustainable health care systems and are ultimately of the interest of patients.
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