Revised Q&As on biosimilars for patients

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During the European Commission’s (EC) second workshop on biosimilars, which was held in Brussels, Belgium on 20 June 2016 [1], the EC presented its new revised question and answer (Q&A) document on biosimilars for patients.

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The document has been published in support of enhancing trust and understanding of biosimilars across Europe. It is a revised version of the consensus information document ‘What you need to know about Biosimilar Medicinal Products’, which was first published in April 2013 and provided patients, doctors and payers with adequate information on the topic [2].

Emma Woodford, Hibou Consulting, who was commissioned to co-lead on the revision process and draft the updated version, gave an overview on the state of play of the revision. The update process was very much focused on consultation with patient representatives in order to address their priorities in a language that is easily understandable despite the fact that it is a highly complex, scientific concept. The leaflet for patients was published together with the EC report on its workshop and is available on the Commision’s website.

The new Q&A document is specifically aimed at patients and still contains all the basics of, for example, what is a biological, a biosimilar, why are biosimilars not generics, information on switching, what to do if you experience a side effect [3].

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1. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Second multi-stakeholder workshop on biosimilar medicinal products; 20 June 2016; Brussels, Belgium.
2. GaBI Online - Generics and Biosimilars Initiative. EU publishes consensus report on biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. EC publishes improved biosimilars information for patients []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from:

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