Clinical Microbiology and Antimicrobial Chemotherapy. 2010; 12(4):314-320
Generic drugs account for 78 to 95% of drug products on the Russian pharmaceutical market and represent a common way of decreasing treatment cost. The main problem of generic drugs is a pharmaceutical quality and comparability between generic and original drug products, which has a significant impact on efficacy and safety of treatment. This paper addresses the issues concerning assessment of generic drugs and their correspondence to original drug product. The key definitions, such as pharmaceutical, pharmacokinetic (bioequivalence) and therapeutic equivalence, are considered. Results of comparative pharmaceutical quality analyses and equivalence studies using several antibiotics (ceftriaxone, cefotaxime, clarithromycin, azithromycin, meropenem) are provided. The problems of governmental regulation of quality control and submission for obtaining marketing authorization for generic drug products in Russia are discussed.