The document, which was developed by the European Medicines Agency (EMA), in collaboration with the EC, aims to improve trust and confidence in the use of biosimilars. Although safe and effective biosimilars have been used in Europe for more than 10 years, questions related to the development, approval and use of biosimilars in practice prompted EMA and the EC to develop this reference information guide.

Juan Garcia Burgos, Head of Public Engagement at EMA gave an overview on the guide, which, although intended for healthcare professionals, also provides a comprehensive guide for all audiences to clarify the biosimilars concept, development and regulatory process.

The guide was published in May 2017 to coincide with the EC workshop and is available on the EMA website.

New guide on biosimilar medicines for healthcare professionals: Increasing understanding of biosimilar medicines
Date: 5 May 2017
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2017/05/WC500226758.pdf

The EC has also published a biosimilar question and answer (Q&A) document for patients in 23 languages [2].

Related articles
Building confidence in biosimilars

Collaborative approach to use of biosimilars

National experience with public procurement of biosimilars

EC workshop aims to improve access to biosimilars 

References
1.  European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Multi-stakeholder Workshop on Biosimilar Medicinal Products; 5 May 2017; Brussels, Belgium.
2.  GaBI Online - Generics and Biosimilars Initiative. EC publishes biosimilar Q&A doc for patients in 23 languages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 23]. Available from: www.gabionline.net/Biosimilars/General/EC-publishes-biosimilar-Q-A-document-for-patients-in-23-languages

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