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Biosimilars in the EU

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Information guide for healthcare professionalsBiosimilars in the EUPrepared jointly by the European Medicines Agency and the European CommissionTable of contentsForeword 2Summary 3Biological medicines: overview 5Key features of biological medicines 5Biosimilar medicines: definition and features 8Why Biosimilars are not considered generic medicines 10Development and approval of Biosimilars in the EU 12A robust regulatory framework for Biosimilars 12Process for approval of Biosimilars in the EU 12Data requirements for approval: a scientifically tailored package 12Immunogenicity 20Extrapolation

Information guide for healthcare professionals Biosimilars in the EU Prepared jointly by the European Medicines Agency and the European Commission

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