Biosimilars in Hematology: Increasing Choice, Expanding Access

Abstract

Biologicals have revolutionised modern medicine by offering vital therapeutic options to treat or prevent complex, disabling, and life-threatening diseases. Between 2013 and 2018, seven of the top ten pharmaceuticals worldwide will be biologicals; however, growing demand, combined with historically-limited competition, will continue to strain healthcare budgets and limit patient access to these treatments. Since 2006, when the first biosimilar Omnitrope® was approved in Europe, 18 other biosimilars, including the first biosimilar monoclonal antibody (mAb), infliximab (approved in 2013), have received marketing authorisation with many others currently in development. There is now extensive clinical experience with biosimilar epoetin (EPO) and filgrastim in patients with cancer, and many studies have reported comparable efficacy with the originator products, no unexpected safety concerns, and significant economic savings. Nevertheless, misconceptions concerning biosimilars remain. This educational session discussed these issues and gave an overview of biosimilar use in hematology. Dr Joerg Windisch highlighted the particular challenges and considerations associated with the development of biosimilars while Prof Steffen Thirstrup covered the approval of biosimilars from the regulatory perspective. Dr Wojciech Jurczak gave a presentation on the development of biosimilars in hematology, with a particular focus on rituximab from a clinical perspective. Dr Paul Cornes concluded with the opportunities that the introduction of biosimilars offer in terms of health economics and improved patient access to care.