EMA biosimilars guidance for healthcare professionals

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The European Medicines Agency (EMA) announced on 5 May 2017, during the agency’s third stakeholder event on biosimilars, that it had introduced a new information guide on biosimilars for healthcare professionals.

Guidance V13F21

The guide entitled ‘Biosimilars in the EU: Information guide for healthcare professionals’ is a joint initiative of EMA and the European Commission. It was developed in collaboration with European Union (EU) scientific experts, in response to requests from healthcare professionals. 

The guide aims to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars. It includes sections on why biosimilars are not considered generics, development and approval of biosimilars in the EU, safety of biosimilars, as well as interchangeability, switching and substitution. The document also contains a section to help healthcare professionals in communicating with patients on biosimilars. 

The document comes as a result of collaboration with ‘organizations from across the EU representing doctors, nurses, pharmacists and patients’ who, according to EMA, ‘shared useful views, to ensure that the guide adequately addresses questions relevant to healthcare professionals’. 

This guide for healthcare professionals follows a question and answer (Q&A) document for patients, which EMA published in January 2017, in support of enhancing trust and understanding of biosimilars across Europe [1].

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1. GaBI Online - Generics and Biosimilars Initiative. EC publishes improved biosimilars information for patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. Available from: www.gabionline.net/Biosimilars/General/EC-publishes-improved-biosimilars-information-for-patients

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Source: EMA

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