An increase in medical expenditures has led health care providers and authorities to implement measures to minimize costs and maximize cost savings. Brand-name medications are typically 30%–60% more expensive than their generic counterparts.
As a result, an increased use of cheaper generic prescription drugs as alternatives to more expensive branded products is encouraged by health authorities worldwide. In contrast to innovator drugs, comprehensive clinical trial evidence is not mandatory for approval of generic drugs by national authorities.
However, generic drugs approved by national regulatory authorities must be bioequivalent to the brand-name version. In essence, the bioequivalence of 2 products is determined by their relative comparability in terms of pharmacokinetic and pharmaceutical equivalence. Specifically, products are bioequivalent if the pharmacokinetic properties of the comparator compound fall within prescribed limits relative to the reference compound. For example, the US Food and Drug Administration (FDA) and European regulations consider the products to be bioequivalent if the mean maximum concentration achieved, the time at which that concentration is achieved, and the area under the concentration–time curve for the generic product falls within 80%–125% of the innovator or branded product, when administered under a fed or fasting state