Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars

Center for Biosimilars

24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from the EMA and the Federal Institute for Drugs and Medical Devices in Germany, published a new paper in which the team outlines the extent of clinical confirmation of biosimilarity, taken together with analytical and functional data, that is considered necessary for biosimilar drugs to be approved in Europe.

In recent months, the discussion about whether the biosimilar development paradigm can be made more efficient has gained new strength, with the publication of papers that argue that some studies generally undertaken to facilitate biosimilar approval are unnecessary or even unethical in nature.

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Michael Wonder

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Michael Wonder