Tag Archives: non-EEA authorised comparator in clinical studies

European Medicines Agency publishes its revised overarching guideline on biosimilars; possibility for medicines developers to use non-EEA authorised comparator in clinical studies

EMA to allow use of non-EEA authorised comparator in clinical studies; new guidance applicable as of today LONDON, 30-10-2014 — /EuropaWire/ — The European Medicines Agency (EMA) has published its revised overarching guideline on biosimilars. The main change brought by this … Read the full press release