EDQM on biosimilars: Ph. Eur. monographs are flexible and evolving standards

EDQM 15/02/2017 Strasbourg, France

During a seminar coorganised with the European Medicines Agency (EMA), the EDQM clarified further the role that Ph. Eur. monographs play in the assessment of biosimilars. As public standards for the quality of medicines in Europe, monographs ensure the quality of biosimilar and other...

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