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The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) clarified that European Pharmacopoeia (Ph. Eur.) monographs ensure the quality of biosimilars and biotherapeutics, but compliance with monographs does not demonstrate biosimilarity. During a Feb. 8, 2017 seminar organized by the European Medicines Agency, EDQM stated that Ph. Eur. monographs, which provide tests and acceptance criteria, “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 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.”