title: Generic products of antiepileptic drugs (AEDs): is it an issue?
abstract: The availability of generic products of antiepileptic drugs (AEDs) has raised the following concerns: (1) Do generic AEDs work as well as brand AEDs in terms of their efficacy, safety and quality? (2) Can generic AEDs be used as substitutions for brand AEDs? and (3) Can generic products of AEDs be used interchangeably? The traditional average bioequivalence analysis addresses concern 1 but does not provide a complete adequate response to concerns 2 and 3. Drug interchangeability can be classified as drug prescribability or drug switchability. Drug prescribability refers to the situation where a patient is treated for the first time so that either a brand or a bioequivalent generic AED can be chosen. Drug switchability refers to the situation in which a brand AED is switched to a bioequivalent generic product of the same AED. The traditional average bioequivalence approach is sufficient to evaluate the prescribability of generic products, but does not ensure the switchability between prescribable formulations. The necessity of assuring switchability of two formulations can be addressed by individual bioequivalence. While the switch to generic AEDs is well tolerated by many patients and in general cost-effective, seizure control should not be sacrificed on the basis of cost alone, as the major end point in treating epilepsy with AEDs is seizure control without side effects. Until we have individual (within patient) bioequivalence data on generic AEDs and/or the tools to a priori identify the subset of patients susceptible to the generic switch, a switch of AED products in seizure-free patients is not recommended.
authors.affiliation: Department of Pharmaceutics, School of Pharmacy and David R. Bloom Center for Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel. bialer@md.huji.ac.il
authors.forename: Meir
authors.initials: M
authors.lastname: Bialer
mesh_terms: D000927:Anticonvulsants / Q000191:economics / Q000592:standards / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical / Q000592:standards; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D011307:Drug Prescriptions / Q000592:standards*; D004361:Drug Tolerance; D016568:Drugs, Generic / Q000191:economics / Q000592:standards / Q000627:therapeutic use*; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D013810:Therapeutic Equivalency
chemical_list: D000927:Anticonvulsants; D016568:Drugs, Generic