The European Commission (EC) and the European Medicines Agency (EMA) have published an information guide on biosimilars aimed at healthcare professionals in 23 languages.
The guide, which is called ‘Biosimilars in the EU: Information guide for healthcare professionals’ is a joint initiative of EMA and the EC and was first published in English in May 2017 [1]. It has now been launched in 23 official languages of the European Union (EU).
The document was developed in collaboration with EU scientific experts, in response to requests from healthcare professionals and includes chapters covering:
• An overview of biologicals
• Definitions and features for biosimilars
• Why biosimilars are not considered generics
• Development and approval of biosimilars in the EU
• Safety of biosimilars
• Data included in the prescribing information and EMA assessment reports for biosimilars
• Responsibilities of EMA and Member States with respect to interchangeability, switching and substitution
• Communicating with patients on biosimilars
• EU contribution to the regulation of biosimilars worldwide
The guide states that the aim of biosimilar development is to demonstrate biosimilarity – high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile. It points out that over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.
Biosimilar competition can offer advantages to EU healthcare systems, as it is expected to improve patients’ access to safe and effective biological medicines with proven quality. However, the guide also points out that EMA does not regulate interchangeability, switching and substitution of a reference medicine by its biosimilar. These fall within the remit of EU Member States.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA biosimilars guidance for healthcare professionals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Guidelines/EMA-biosimilars-guidance-for-healthcare-professionals
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