The European Medicines Agency (EMA) and the European Commission have developed information materials on biosimilar medicines to improve understanding of these medicines in the European Union (EU). They have published an information guide to provide reference information on the science and regulation underpinning the use of biosimilar medicines. The publication entitled ‘Biosimilars in the EU – Information guide for healthcare professionals’ was first published in May 2017 and last updated in October 2019.
EU scientific experts and organisations representing doctors, nurses, pharmacists and patients contributed to the development of this guide. The guide is now available in 23 official EU languages. It was translated into 15 additional official EU languages: Bulgarian, Croatian, Czech, Danish, Greek, Estonian, Finnish, Hungarian, Lithuanian, Latvian, Maltese, Romanian, Slovak, Slovenian and Swedish. It was already available in Dutch, English, French, German, Italian, Polish, Portuguese and Spanish. All translations are available here.
In addition, an information guide for patients published by the European Commission explains 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. EMA and organisations representing patients contributed to the development of this guide. It is available in 23 official EU languages on the European Commission’s website.
Furthermore, an animated video for patients explains key facts on biosimilar medicines and how EMA works to ensure that they are as safe and effective as their reference biological medicines.
EMA's scientific committees evaluate the majority of marketing authorisation applications for biosimilar medicines before they can be approved and marketed in the EU.
EMA evaluates biosimilars according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines approved in the EU.
Biosimilars can only be authorised once the period of data exclusivity on the reference biological medicine has expired. In general, this means that the biological reference medicine must have been authorised for at least eight years before another company can apply for approval of a similar biological medicine.
A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (called reference medicine) in terms of structure, biological activity and efficacy, safety and immunogenicity profile.
The EU approved the first biosimilar in 2006.
A biosimilar is not regarded as a generic of a biological medicine. This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular micro-heterogeneity.
The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally.
The evidence acquired over ten years of clinical experience shows that biosimilars approved through EMA can be used as safely and effectivelyin all their approved indications as other biological medicines.
You can find the list of biosimilar medicines approved via the centralised procedure on EMA webpage on centrally authorised biosimilar medicines.