Brand-name products and generics: an issue?
Grigor'eva N.Yu.

Nizhny Novgorod State Medical Academy

The results of recent (though few) studies demonstrate that generics are not similar or equal to the brand-name drugs.
Aim. To compare therapeutic equivalence of brand name bisoprolol/Concor (Merck, Germany) and generics, i.e., Biprol (Makiz-Pharma, Russia), Biol (Sandoz, Slovenia), and Niperten (KRKA, Slovenia) in patients with stable angina and chronic obstructive pulmonary disease (COPD).
Patients and methods. The study included 122 patients. Group I (n = 36) received brand name bisoprolol/Concor, group II (n = 36) received generic Biprol, group III (n = 30) received generic Biol, group IV (n = 20) received generic Niperten. Endothelium-dependent vasodilatation test, daily ECG monitoring, and external respiration test were performed; lipid peroxidation was assessed as well.
Results. All groups demonstrated similar hypotensive and anti-ischemic effects after 12 weeks of the treatment. However, significant improvement of endothelial function and lipid peroxidation was observed in group I only.
Discussion. The inhibition of catecholamine effects on adrenergic receptors is the major effect of beta-blockers. Hyper-activation of sympathetic adrenal system through the oxidative stress and endothelial dysfunction determines the rate of the development of cardiovascular events. Our data suggest that brand-name bisoprolol reduces oxidative stress in patients with coronary heart disease and COPD. Unlike generics, brand-name product seems to act on molecular and cellular levels.
Conclusions. Despite similar hemodynamic parameters, brand-name bisoprolol demonstrates significant clinical efficacy as compared with generics due to the positive effect on disease progression mechanisms.

Key words: brand-name product, generic, bioequivalence, therapeutic equivalence, stable angina, chronic obstructive pulmonary disease, endothelial dysfunction, lipid peroxidation, bisoprolol, Concor.

For citation: Grigor'eva N.Yu. Brand-name products and generics: an issue? // RMJ. 2016. № 19. P. 1301–1307.