Generic drugs : the pros and cons

After explaining the EU rules on generic drugs, their assessment will be discussed. Differences between generic drugs and copy cats will also be examined. Generics definition as well as the EMEA / CVMP / 016 / 001 directives will help us define the assessment criteria of these drugs. Depending on the drug presentation, bioequivalence criteria are different: a! cid dissolution studies, pharmacokinenetic curves (Cmax, Tmax, AUC, T1/2). Therefore, generic drug limits will be underlined: difference between bioequivalence and efficacy. Assessment criteria variability (20 to 30%) can induce therapeutic differences. Moreover, a switch during long term treatment can induce tragic incidents. A review of human incidents will be exposed to enhance potential risks in veterinary medicine. We will also discuss the fact that antibiotic resistance emergence with generic drugs is more likely to happen than with original drugs. Finally, interest of generic drugs in veterinary medicine will be looked at. The economic and social roles of generic drugs in human medicine will be distinguished from their role in veterinary medicine.