The Scientific Challenge
In 2007, in response to long-standing concerns among some patients and physicians that generic versions of drugs to treat epilepsy can lead to loss of seizure control, the American Epilepsy Society (AES) took a position opposing the substitution of generic epilepsy drugs for patients without the consent of physicians and patients. However, no scientific studies comparing generic and brand name antiepileptic drugs had been conducted. Although they were meant to protect patients, the recommendations would likely raise costs and limit the availability of new generics.
FDA’s Collaborative Research to Determine the Bioequivalence of Brand Name and Generic Antiepileptic Drugs in Patients
Since 2010, FDA has led a collaborative effort to address these concerns by conducting three pivotal clinical trials in patients with epilepsy: the Bioequivalence in Epilepsy Patients (BEEP) studyExternal Link Disclaimer and the Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy (EQUIGEN) multipleExternal Link Disclaimer – and single-dose studiesExternal Link Disclaimer . In designing and conducting these trials, FDA reached out to academic medical centers, the National Institute of Neurological Disorders and Stroke, and AES to bring together key expertise and perspectives.
The BEEP study compared lamotrigine with the brand name version, Lamictal. Investigators studied 38 high-risk patients (those who reported problems or more seizures when switched to the generic). The patients were repeatedly switched between brand name and generic versions to compare the bioequivalence (as indicated by area under the curve and maximum concentration achieved) and study within-patient variability. The study found the generic was bioequivalent to Lamictal and had similar within-patient variability, providing strong evidence that the two drugs could be used interchangeably. No significant differences in control of epileptic seizures were observed…