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Biosimilars in the EU

Information guide for healthcare professionalsBiosimilars in the EUPrepared jointly by the European Medicines Agency and the European CommissionTable of contentsForeword 2 Summary 3 Biological medicines: overview 5 Key features of biological medicines 5 Biosimilar medicines: definition and features 8 Why Biosimilars are not considered generic medicines 10 Development and approval of Biosimilars in the EU 12A robust regulatory framework for Biosimilars 12 Process for approval of Biosimilars in the EU 12 Data requirements for approval: a scientifically tailored

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 …

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