Brand-Name Versus Generic AEDs: Are They Really Any Different?

Analysis of bioequivalence studies suggests that switching between brand-name and generic antiepileptic drugs is relatively safe but that generic-to-generic switching might increase the risk for adverse effects.

A major concern for epilepsy patients and their caregivers is the switch from brand-name antiepilepsy drugs (AEDs) to generic formulations. Switching to or starting on generic AEDs has become mandatory for the vast majority of epilepsy patients in the U.S., since nearly all the newer-generation AEDs are now available in generic formulations. These authors analyzed bioequivalence studies required for Abbreviated New Drug Applications submitted to the FDA, obtained via Freedom of Information Act requests, to answer the central question of whether generic AEDs are accurate copies of brand-name drugs. They also addressed whether switches between generic formulations are safe and effective.

Data from 141 generic formulations of the following AEDs…

Reviewing Author

Robert C. Knowlton, MD, MSPH

Disclosures

Consultant/Advisory BoardMore Health, Inc.; The Alliance of Medical Companies

Grant/Research SupportNIH Small Business Innovation Research

Leadership Positions in Professional SocietiesSouthern Epilepsy & EEG Society (Treasurer)

Robert C. Knowlton, MD, MSPH

Disclosures

Consultant/Advisory BoardMore Health, Inc.; The Alliance of Medical Companies

Grant/Research SupportNIH Small Business Innovation Research

Leadership Positions in Professional SocietiesSouthern Epilepsy & EEG Society (Treasurer)