Sunday, 28 May 2017

Biosimilars (EDQM News)


EDQM Biosimilars: Ph. Eur. monographs are flexible and evolving standards During a seminar co-organised 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 biotherapeutic products, but compliance with them is not sufficient for demonstrating biosimilarity.

However, while Ph. Eur. monographs provide specifications in the form of tests and acceptance criteria for all medicines, they are dynamic documents that can be adapted to scientific progress.

Dr Peter Richardson, Head of Quality at the EMA, provided information on EU legislation in the field of biosimilars, and Dr Niklas Ekman, Senior Researcher at the Finnish Medicines Agency (FIMEA) shared his experience as an assessor.

See: biosimilars seminar from which a video recording of the EDQM-EMA session on biosimilars can be viewed



Posted by Dr. Tim Sandle