When the patent of a small molecule drug expires, generics may be introduced. They are\nconsidered therapeutically equivalent once pharmaceutical equivalence (i.e.,, identical active\nsubstances) and bioequivalence (i.e., comparable pharmacokinetics) have been established\nin cross-over volunteer study. However this generic paradigm cannot be applied to complex\ndrugs as biologics. For copies of biologics EMA, and FDA, have introduced a new regulatory\nbiosimilar pathway which mandate clinical trials to show therapeutic equivalence. However\nfor some complex drugs, such as iron-carbohydrate drugs, liposomal drugs, glatiramoids\n(named Non Biologic Complex Drugs [NBCD]), regulatory guidance is still mostly lacking. In\nthis paper we will discuss therapeutic experiences with these different classes of complex\ndrugs and their specificity, to provide scientific arguments for consideration for a new\nregulatory framework.
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