by Lentano Ciro May 30, 2014 – quelchefarmacia magazine
In recent months, thanks to the detail analysis of the pharmaceutical expenditure aimed at containing, while not giving up quality and safety, it has placed a topic of great interest in the spotlight, often gone unnoticed, inherently the generic drugs and i, certainly more known and currently more widespread, branded drugs whose primary differentiation, in inexperienced eyes, resides in the purchase and sale price, certainly higher for the second, From the patents to the center of large discussions also at the Ministry of Health. In order to fully understand the real differences between the two types in the light of health policies increasingly tending in favor of generics for cost containment, it is therefore advisable to analyze the experimentation phases, the relative derived expense, and above all the safety parameters provided by the drugs compared, since in reality the phases are not complementary or completely similar. In fact, branded drugs are structured around trials, with a preclinical and clinical phase, lasting 12 and 8-10 years, the first and second respectively, followed by a third follow-up phase during the first years of marketing, for confirmation of the effects or possible withdrawal from the market with costs ranging from 1 to 600 million dollars, aspects absent in generic drugs which, by exploiting the expired, no longer exclusive, patent can market the product under a different trade name, but with the same active ingredient. immediately, having a guarantee of clinical tests and safety and presenting only a simplified technical dossier for the certification of bioequivalence. Given the obvious difference in costs between branded and generic drugs, derived precisely from the diversification of trials and experimental studies, safety represents another parameter that should not be underestimated, an aspect which in reality, despite the guarantee provided by the patent, both in exclusivity and in expiry, as outlined by Luca Galli, professor of Clinical Pharmacology at the University of Catanzaro, would lean more towards branded ones due to the continuous tests to which they would be subjected for AIFA validation, something partially absent on generics, developed on safety reflecting the data that emerged on the first tests: “In general, all drugs placed on the market and therefore evaluated and validated through the Marketing Authorization by AIFA should be safe. However, branded drugs compared to generic drugs are subjected to toxicity studies (Preclinical studies) and safety studies (Clinical studies) in order to evaluate, and therefore predict, the risk of developing adverse events in the population after marketing".
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