Improving understanding of biosimilars in the EU

EMAThe European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a 'reference' biological medicine already authorised.

The new material includes an animated video for patients that explains key facts on biosimilar medicines and how EMA works to ensure that they are as safe and effective as their reference biological medicines. The video is available in eight European languages: Dutch, English, French, German, Italian, Polish, Portuguese and Spanish.

The other documents published today are the translations of the biosimilar guide for healthcare professionals into Dutch, French, German, Italian, Polish, Portuguese and Spanish. The guide, which was first made available in English in 2017, provides healthcare professionals with comprehensive and easily understandable information on both the science and the regulation underpinning the use of biosimilars.

These newly published materials complement the Questions & answers on biosimilars for patientsExternal link icon in 23 EU languages previously made available by EMA and the European Commission. In addition, as for all medicines, the Agency publishes a public friendly overview which explains why the biosimilar medicine has been approved for use in the EU.

Biosimilar medicines offer alternatives to patients and doctors in the EU and so increase the availability of biological treatments for patients who need them.

The newly available materials will be presented at the European Commission’s fourth multi-stakeholder conference on biosimilar medicines in Brussels on Friday, 14 September 2018. This conference aims to promote the exchange of information and expand patients' and healthcare professionals' knowledge on biosimilar medicines. The discussion will focus on three main topics: biosimilars in oncology, sustainable procurement and educational activities to improve understanding of biosimilars.

To find out more about biosimilars visit the webpage on biosimilar medicines.