Debate: Substitution of generic drugs in epilepsy: is there cause for concern?

The role of generic drugs in both the US and global marketplace has been steadily increasing over the last few years. Although generic drugs clearly represent an important economic alternative for many patients, there are reasons for concern in certain disease states. Recently, the substitution of antiepileptic drugs in patients with epilepsy has gained increased attention. Concerns over potential therapeutic inequivalence has prompted many clinicians to question current regulatory requirements for both establishing bioequivalence, as well as product substitution. The objective of this article is to present arguments both for and against the use of generic drugs and practice of generic substitution in patients with epilepsy. Regulatory requirements, pharmacokinetic methodology, and biopharmaceutical considerations are discussed.