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Hi everyone,
Something which puzzles me as I read through the regulatory guidelines for BCS-based biowaivers: why does the FDA require the BCS classification of a drug substance to be redone for a BCS-based biowaiver when this would have been done for the innovator drug substance anyway? I note that the EMA seems to be of the opposite opinion. As far as the formulations are similar, I would not expect the classification to be any different between the innovator and the generic, so is this not a duplication of work?
Perhaps I have missed some crucial link in the thinking behind this, so I would be happy to hear any educated opinions.
Thanks and regards,
Clare
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