25 March 2018 - This study gives an update regarding biosimilar development in practice by reviewing the clinical development programs of recently approved biosimilars in Europe.

The European public assessment reports (EPAR) which are published by the European Medicines Agency (EMA) were used for a comparison of the clinical development programs of the 37 approved biosimilars in Europe. Novel strategies in biosimilars development were presented by focussing specifically on the 17 biosimilars that gained approval in the last year, but we also compare additional key characteristics for all approved biosimilars.

European regulators still seem to be open to consider approaches that differ from the guidelines or previous applications as long as justification is provided.

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