Roaccutane® of generieke producten met isotretinoïne?

Substitution of brand-name drugs by generic formulations is still subject of discussion. It is questionable whether all generics are truly bioequivalent to their brand-name counterparts. The tests currently used in the EU cannot entirely rule out the possibility of differences in drug exposure leading to an increase or decrease in drug efficacy and toxicity. Comparative investigation in the UK between Roaccutane® (USA: Accutane®) and 14 generic preparations containing isotretinoin revealed many pharmaceutical differences. One of these (strong variations in particle size) may be the cause of differences in absorption spectra, leading to elevated or decreased plasma concentrations of the drug with possible clinical consequences. Preferentially prescribing generics with isotretinoin over Roaccutane® does not result in cost savings and has no other obvious advantages. In the Netherlands, the pharmacist is not allowed to deliver a generic product when a brand-name drug has been prescribed without consent of the prescriber and the patient.