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 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.
“Ph. Eur. monographs do evolve to reflect product heterogeneity dependent on process, and this aspect is of particular relevance for manufacturing biotherapeutic products”, explained Dr Susanne Keitel, Director of the EDQM, adding that “current legislation purposely allows for monographs to be complemented with further specifications that may be needed to adequately control the quality of a given substance produced through a specific route”.
The event was also an opportunity for Dr Peter Richardson, Head of Quality at the EMA, to provide information on EU legislation in the field of biosimilars, and for Dr Niklas Ekman, Senior Researcher at the Finnish Medicines Agency (FIMEA) to share his experience as an assessor. Their presence in Strasbourg testified to the EU’s leading role in the field of biosimilars, as well as to the strong partnership between the EDQM and the EMA in ensuring patient safety in Europe.
The seminar, which took place on 8 February and was attended by 200 participants from 37 countries around the world, was part of the EDQM’s commitment to reaching out to stakeholders and ensuring constant dialogue on the role of the Ph. Eur. in the development of safe medicines for the benefit of all Europeans.