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.
by Paul Cornes
Cancer is the world’s biggest killer, and the complex biological medicines used to treat it are expensive. Even the world’s richest countries will struggle with the cost of these drugs and so tackling the issue of affordable cancer care is something we need to address now. One of the solutions could be biosimilars. But what are they, do we need them and are they similar enough to the originator products to use them safely in our patients? Opinion is divided among physicians but some experts say this is down to a lack of information and education. We interviewed top biosimilars expert, Dr Paul Cornes, on this burning subject, which is dividing opinions in the field of oncology. Dr Cornes discusses the cost of biologic medicines, the introduction of biosimilars and the regulatory pathways that have been put in place to ensure safety and efficacy remains. He talks about the methods by which biosimilars can be ‘extrapolated’ across multiple indications, as well as touching on some interesting insights into the manufacturing of the biologic molecules that oncologists have been using, without question, for years. Watch the entire comprehensive interview series soon on http://www.VJHemOnc.com to find out if the dream of affordable cancer care can come true. This programme has been supported by Napp Pharmaceuticals Ltd through an unrestricted educational grant to Magdalen Medical Publishing.
