This document has been developed to explain to patients in a clear, unbiased way what biosimilar medicines are, how they are developed and approved in the EU, and what patients can expect in terms of availability and safety.
Biological medicines (including biosimilar medicines) come from living organisms, such as living cells that have been modified using biotechnology.
A biosimilar medicine is developed to be highly similar to an existing biological medicine. This existing biological medicine is a medicine that has already been approved and is used in the EU and referred to as the reference medicine. After the patent ends for the reference medicine and it finishes its exclusivity term, the biosimilar medicine is allowed to come onto the market.
How are biosimilar medicines developed and approved in the EU? Who decides on the availability of biosimilar medicines in particular countries? Where can I get more information on biosimilar medicines?
This consensus information document is designed to answer these questions. It was drafted for and by patients together with representatives of the European Medicines Agency and the European Commission in conjunction with the European Patients Forum (EPF), the European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA), the Standing Committee of European Doctors, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bioindustries (EuropaBio) and Medicines for Europe] .
It is available in 7 languages (English, French, German, Italian, Polish, Portuguese and Spanish).