Generic Medicines

Abstract

The present definition of the World Health Organization (WHO) for generic bioequivalent drug, the adoption of this concept by the countries of best sanitary development and the situation of Chile on the matter, are analyzed. Through examples of studies of bioavailability and bioequivalence (BD/BE) done in Chile we discuss the concepts of therapeutic equivalence, quality, safety and effectiveness of the drugs. We also list drugs that according to Chilean legislation must be submitted to this kind of studies and those will be able to choose in vitro studies (for example dissolution tests) in order to prove therapeutic equivalence. Also the situation of the drugs which do not require BD/BE studies, as for example intravenous injections, syrups and others is discussed. Finally, we recommended what to do with products of biotechnological origin.