Abstract
Antibiotics are available as innovators and generics. An innovator or branded drug is a medicine that is discovered, developed and marketed by a pharmaceutical company which also holds the patent for that drug. Generics only become available after the patent on the innovator expires. Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the innovator product. Generics should be bioequivalent to the innovator and when used, should have the same efficacy and safety profile. This is crucial for parenteral antibiotics because according to the World Health Organization and U.S. Food and Drug Administration criteria, parenteral generic products do not need to provide evidence for in-vivo bioavailability or bioequivalence before they can be marketed. Published evidence shows that there is a disparity in the efficacy of different generic antibiotic products. In-vitro microbiological methods of efficacy testing have been recognized as a standardized and cost-effective approach to clarify doubts regarding the efficacy of generic parenteral antibiotics. However, in-vitro methods used alone, might not be a good measurement of antibiotic efficacy as several studies have shown disparities between in-vitro and in-vivo efficacy of parenteral antibiotics.
Highlights
Antibiotics, the choice of treatment for bacterial infections, have greatly reduced illness and death from infectious diseases and helped to improve life expectancy
No difference was observed in Minimal Inhibitory Concentration (MIC), Minimal Bactericidal Concentration (MBC) and MIC/MBC ratio between tested products There were no differences in the MIC, MBC and MIC/MBC ratio in the innovator and 9 generic products No significant difference was observed in MIC
The implication of in-vitro results alone to determine the efficacy of parenteral antibiotics may not yield optimum results
Summary
Antibiotics, the choice of treatment for bacterial infections, have greatly reduced illness and death from infectious diseases and helped to improve life expectancy. No significant difference was observed in the in-vitro test, but all generics failed to achieve innovator’s maximum effect in the in-vivo test These studies highlight the importance of testing the in-vivo efficacy of parenteral antibiotics this is not required by drug regulatory authorities. Three in-vitro studies adopted the agar diffusion test as an alternative to MIC and MBC These researchers compared the diameters of the zone of inhibition between different brands of antibiotics to determine efficacy. Other authors have reported similar MIC/MBC values for innovator and generic products and concluded that there was no difference in efficacy according to the in-vitro test results. The majority of published data does not show significant pharmacokinetic differences when invitro and in-vivo efficacy comparisons were done simultaneously.[13] While the in-vitro efficacy (MIC and MBC) was comparable, the therapeutic efficacy of generic and innovator products showed variability. Selection of resistant bacterial subpopulations were same magnitude for the innovator & generics
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