Truxima® is Rituximab

Watch an overview of the main topics covered in the article here, including the economics, chemical similarity, regulation and safety of biosimilars

What are biosimilars and how are they approved?

The European Medicines Agency regulation of biosimilar production is based on the procedures that are in place for assessing manufacturing changes of originator biologics. Central to this is demonstrating that there are no significant clinical differences between a biosimilar and its reference biologic. In this video, Martin Dyer, DPhil, FRCP, FRCPath, explains that the step-wise approach to the regulation of biosimilars is no less stringent to originator biologics, but that the balance of data required is different.

EUROPEAN MEDICINES AGENCY INFORMATION GUIDE FOR HEALTHCARE PROFESSIONALS ON BIOSIMILARS IN THE EU (2017)