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.
Posted by Dr. Tim Sandle
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