Article · Volume 4, Issue 4S · pp. S110–S111

Safety and efficacy of generic drugs with respect to brand formulation

Luca Gallelli¹, Caterina Palleria², Antonio Vuono³, Laura Mumoli³, Piero Vasapollo³, Brunella Piro³, Emilio Russo³

¹Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy and Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.
²Department of General Medicine, ASP Cosenza, Italy.
³Department of Pharmacovigilance, ASP Cosenza, Italy.

Abstract

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

Keywords: Antibiotics; bioequivalence; brand; clinical efficacy; generic; safety

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