2018 issue 1


Volume 34, issue 1

Review article

Bioequivalence of medicinal products

Grzegorz Cessak1, Ewa Bałkowiec-Iskra1,2
1. Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
2. Katedra i Zakład Farmakologii Doświadczalnej i Klinicznej, Warszawski Uniwersytet Medyczny w Warszawie
Farmakoterapia w Psychiatrii i Neurologii 2018, 34 (1), 9–21
Date of publication: 18-05-2018
DOI: http://dx.medra.org/10.17393/fpn.2018.01.001
Keywords: bioequivalence, psychotropic medicinal products, reference medicinal products, generic medicinal products


Aim. The aim of the present study was to summarise data regarding registration of generic medicinal products.

Data analysis. Introduction of equivalents of referencemedicinal products (also described as generic drugs) intomedicine has allowed patients to have broad access tonewest pharmacotherapy methods and significantly lowered treatment cost. Equivalents of reference medicinal products obtain marketing authorisations aftertheir bioequivalence to relevant reference products (alsodescribed as "innovative products") is proven in bioequivalence studies. Requirements for these studies areprecisely set by competent regulatory agencies.

Conclusions. Even though all generic medicinal prod-ucts currently on the market fulfil the requirements forquality and biological equivalence, some patients mayexperience transient symptoms of therapeutic equivalence disturbances. As this phenomenon is unpredict-able, assessment of patient clinical status is requiredduring first weeks after the switch from reference drugto generic. Dose adjustment may be necessary. However, sometimes deterioration of symptoms may also resultfrom natural progression of the disease.

Address for correspondence:
Ewa Bałkowiec-Iskra
Katedra i Zakład Farmakologii Doświadczalnej i Klinicznej
Warszawski Uniwersytet Medyczny
ul. Banacha 1b, 02-091 Warszawa, Poland
email: ebalkowiec@wum.edu.pl