Transcription of Biosimilars in the EU
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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 package 12 Immunogenicity 20 Extrapolation
Information guide for healthcare professionals Biosimilars in the EU Prepared jointly by the European Medicines Agency and the European Commission
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