Bioequivalence and therapeutic equivalence of psychotropic drugs

ObjectiveIt is the objective of this paper to discuss the requirements that must be met by generic drugs and explain basic concepts relating to bioequivalence. The authors have also included two tables listing the trading names of antidepressants and antipsychotics, with a valid authorization for marketing in Poland, which might prove helpful in daily psychiatric practice.ViewsThe introduction of regulations which enabled the registration of drugs equivalent to reference medicinal products (so-called generic drugs) has been one of the main breakthroughs in the psychiatric pharmacotherapy. Breaking with the monopoly resulted in lower prices and increased the accessibility of modern treatment methods. On the other hand, the effective period of market exclusivity is also the post-marketing period of monitoring for the safety and efficacy of these medicinal products.ConclusionsDrugs equivalent to reference (branded) products are the latest, up-to-date form of treatment, though their safety profile and efficacy are already well-known, owing to the long presence of the active substance on the market. Most of the publications confirm the therapeutic equivalence between the branded and generic antipsychotics and antidepressants. However, one should also keep in mind a potential change in the patient's clinical condition after replacing a reference product with its generic equivalent.