The failure to show bioequivalence is not evidence against generics.

摘要

I read with interest the paper by Del Tacca et al. [1 ]. I agree that verification of the bioavailability of marketed pharmaceutical products is an interesting topic, since not all marketed products have been shown to be bioequivalent to the reference product. It is only possible to believe naively that all products on the market are bioequivalent with the reference product from the complete ignorance of the pharmaceutical legislation of the European Union [2]. Therefore, a list similar to the FDA Orange Book [3], which identifies the (bio)equivalent products and its reference product, is essential for prescribers. Interestingly, the legislation allowing the authorization of products with unknown bioavailability (e.g. bibliographical applications), but with the dosage instructions of the reference product, or the absence of a 'European Orange Book' are hot criticized. On the contrary, the criticism is motivated by the substitution policies, which affect economically the reference products and prescribers, and are focused on the second-entry products that assure best the safety and efficacy profile and interchangeability with the reference product. Average bioequivalence is not only a surrogate of therapeutic equivalence but also of equivalent biopharma-ceutical quality, which assures that generic and reference products will behave in the same way in all individual patients, irrespective of their demographics, concomitant medication or illnesses.