EMA guidance on facilitating global development of biosimilars

The European Medicines Agency has published its revised overarching guideline on biosimilars, or follow-on biologic medicines. This guideline is one of three EMA overarching biosimilar guidelines, the previous ones issued in 2013 and June this year.

The main change brought by this new guidance is the possibility for medicines developers to use a comparator authorized outside the European Economic Area (EEA) during the clinical investigation of a biosimilar. This new concept is expected to facilitate the global development of biosimilars and to avoid unnecessary repetition of clinical trials.

The revised guideline will come into force as of April 30, 2015. However, applicants can apply some or all provisions of this guideline from today.