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
Summary Since the EU approved the first biosimilar medicine (‘biosimilar’) in 2006, the EU has pioneered the regulation of biosimilars. Over the past 10 years, the EU has approved the highest number
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