European Regulatory Roundup: EMA Finalizes its Biosimilars Guidance (15 January 2014)

Posted in News, World

By Nick Paul Taylor

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Finalizes Another Piece of its Revised Biosimilars Guidance

The European Medicines Agency (EMA) has finalized another piece of its guidance on biosimilars. In the latest update to the pioneering guidance documents EMA introduced in 2005, the regulator details the preclinical and clinical tests developers should perform to demonstrate biosimilarity.

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Orphan Drugs in the EU: A Record-Breaking Year

Posted in News, World

By Michael Mezher

The European Medicines Agency (EMA) recommended 17 drugs with orphan product designation for approval in 2014, the most ever in a single year.

This is much higher than the average of 6.75 per year between 2010 and 2013 and is a significant increase from 2013, when EMA recommended 11 products with orphan designation for approval.

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