Requirements for generic anti-epileptic medicines: a regulatory perspective

Currently, there is a lot of discussion about whether generic substitution of anti-epileptic medicines with the same active moiety but from different manufacturers can take place safely. Issues raised in this discussion relate to bioequivalence requirements, variability in exposure, problems with medicine supply, costs of adverse events, and possible legal consequences when patients do not provide explicit permission for being switched to a generic medicine [ 2 – 6 ]. Furthermore, it is not clear what the consequences are in terms of adverse events, and thus the costs for society and the consequences for the individual patient [ 7 ].