Medicines for Europe Director General Adrian van de Hoven participated in the Open Public Hearing (OPH) of the July 13, 2017 Oncologic Drugs Advisory Committee US FDA Advisory Committee involving biosimilar medicines on 13 July 2017.

• Biosimilar medicines clinical use: an experience based-EU perspective
• The Biosimilar Medicines Group contribution to the US FDA Docket
• For more information please check the official US FDA website

15^th Biosimilar Medicines Conference

BIOSIMILAR MEDICINES: A GAME CHANGER FOR HEALTHCARE SUSTAINABILITY

Friday 24 March 2017 | 10.00 – 10.45 (CET)

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by Robin Foà

Robin Foà, MD from the Sapienza University, Rome, Italy discusses the question of how the trials on biosimilars should be run and what needs to be done for biosimilars to get approved. According to Prof. Foà, this is a difficult question and he points out that the European Medicines Agency (EMA) has stated that extrapolation is acceptable. He talks about the importance of demonstrating the safety and efficacy of biosimilars and discusses when extrapolation may be acceptable. Prof. Foà further argues that it is unrealistic to repeat all trials. Recorded at the European Hematology Association (EHA) 2016 Annual Congress in Copenhagen, Denmark.