The European Medicines Agency (EMA) has published its revised overarching guidelineon biosimilars. The main change brought by this new guidance is the possibility for medicines developers to use a comparator authorised 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 30 April 2015. However, applicants can apply some or all provisions of this guideline from today.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/10/news_detail_002201.jsp&mid=WC0b01ac058004d5c1