EC publishes biosimilar Q&A document for patients in 23 languages Posted 08/12/2017

On 29 November 2017, the European Commission (EC) published a patient-focused Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.
The document, which is called ‘What I Need to Know About Biosimilar Medicines’ has been launched in 23 official languages of the European Union (EU). It contains consensus information on biosimilars that was drafted by representatives from the European Medicines Agency (EMA), the EC, patient groups, prescriber groups and pharmaceutical industry groups. It covers fundamental questions, including: The document also includes questions on extrapolation, switching and policy: It also provides information where patients can find further information and on how they can report side effects to both EMA and to the national regulatory authority: Industry groups, including Medicines for Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have congratulated the EC and EMA on the developments made during the programme to create the document. They added that the group’s work on this and other documents has ‘contributed significantly to the increased understanding and acceptance of biosimilar medicines’. EMA published the first Q&A document for patients on biosimilars back in 2012 [1].
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Revised Q&As on biosimilars for patients
1. GaBI Online - Generics and Biosimilars Initiative. EMA publishes revised biosimilar Q&A document for patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 8]. Available from: www.gabionline.net/Biosimilars/General/EMA-publishes-revised-biosimilar-Q-A-document-for-patients
Source: EMA, EFPIA, Medicines for Europe