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EC publishes improved biosimilars information for patients Posted 27/01/2017

On 23 January 2017, the European Commission (EC) published a unique question and answer (Q&A) document for patients containing reliable information on biosimilar medicines.

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 [1].

The new Q&A document is specifically aimed at patients and still contains all the basics of what is a biological, a biosimilar, why are biosimilars not generics, information on switching, what to do if you experience a side effect. In addition, the document now also contains several new sections covering the following:

  • how biosimilars are approved in the European Union (EU)
  • why all studies with the reference medicine are not repeated with the biosimilar?
  • extrapolation of indications for biosimilars
  • availability of biosimilars in different Member States
  • how to get information about biosimilars
  • the role of the patient, as well as physicians and pharmacists

The document also contains a link to the European Medicine Agency’s (EMA) website where patients can access more information on biosimilars. It also contains a link to EMA’s list of all biosimilars approved in the EU, which will be kept updated as new biosimilars are approved.

The new document is a result of joint stakeholder collaboration and, as well as input from EMA, included input from Medicines for Europe and the European Patients’ Forum, among others.

Related article
Use of biosimilars in Europe

1.    GaBI Online - Generics and Biosimilars Initiative. EU publishes consensus report on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Reports/EU-publishes-consensus-report-on-biosimilars

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Source: EMA,Europa

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