title: Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.
abstract: Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products.
authors: Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland; The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland. Electronic address: ebalkowiec@wum.edu.pl.
authors: Ewa
authors: E
authors: Bałkowiec-Iskra
authors: Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland; The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland.
authors: Grzegorz
authors: G
authors: Cessak
authors: Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland; The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland.
authors: Olga
authors: O
authors: Kuzawińska
authors: Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland.
authors: Katarzyna
authors: K
authors: Sejbuk-Rozbicka
authors: Nowowiejski City Hospital, Poland.
authors: Konrad
authors: K
authors: Rokita
authors: Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland; 2nd Department of Neurology, Institute of Psychiatry and Neurology, Poland.
authors: Dagmara
authors: D
authors: Mirowska-Guzel
mesh_terms: D016568:Drugs, Generic / Q000493:pharmacokinetics / Q000592:standards / Q000627:therapeutic use; D005060:Europe; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D011619:Psychotropic Drugs / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D012042:Registries; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic; D011619:Psychotropic Drugs
keywords: Bioequivalence; Generic medicinal products; Psychotropic medicinal products; Registration