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EMA issues guide to biosimilars in the EU

https://doi.org/10.1136/dtb.2017.7.0499

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    EMA issues guide to biosimilars in the EU

    The European Medicines Agency (EMA) has issued a guide for health professionals on biosimilars.1 The objective of the guide, which is a joint initiative of the EMA and the European Commission, is to provide information on the science and regulation underpinning the use of biosimilars. It was developed in collaboration with EU scientific experts in response to requests from healthcare professionals.

    In principle, biosimilars are the biological medicines equivalent of generic chemical medicines.2 However, chemical drugs are generally low molecular weight …

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