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:

• What is a biological medicine?
• What is a biosimilar medicine?
• How are biosimilar medicines developed and approved in the EU?
• Are biosimilar medicines generic medicines of biological medicines?

The document also includes questions on extrapolation, switching and policy:

• Why can biosimilar medicines be approved for indications for which no clinical studies have been done? What is ‘extrapolation’?
• If I am already being treated with a biological (reference) medicine, can I be switched to its biosimilar?
• Who decides on the availability of biosimilar medicines in particular countries?

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:

• Getting information about treatment and use of biosimilar medicines
• What should I do if I suspect I have a side effect?

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].

Related articles
Revised Q&As on biosimilars for patients

FDA issues another biosimilars Q&A guidance

Reference
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

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