ECCO 2017 | The approval process of biosimilars

Markus Hartmann, PhD, from European Consulting & Contracting in Oncology, Trier, Germany, discusses the approval process of biosimilars at the European Cancer Congress of the European Cancer Organisation (ECCO) 2017 in Amsterdam, Netherlands. Biosimilars are drugs that haven been designed to have the same properties as complex biological molecules, such as monoclonal antibodies. Biosimilars must got through a rigorous process to be approved. They must undergo large comparability studies to prove that they have the same effect patients as the originator, as well as pharmacovigilance follow up. He does state, however, that this leads to a lower cost advantage than with generic drugs.