A bioequivalence study is a study carried out to demonstrate that two drugs, or two different dosages of the same drug, are absorbed in the same way after administration and produce an equal effect on the requested site. Regarding generic medicinal products, the concept of bioequivalence is essential since, for a generic drug to be approved, bioequivalence with the reference (original) medicinal product must be demonstrated. The regulatory authorities evaluate bioequivalence considering two standard measures: the absorption rate and the extent of absorption. If the formulation of a medicine is different concerning one or both parameters, the authorities will determine that it is not bioequivalent to the reference product.
These days, pharmaceutical bioequivalence study is in vogue after the Institute of Public Health certified 70 medications with this characteristic. It is an attribute that allows two medicines of different origin of manufacture, contain the same active ingredient and quantity, and their absorption is in quantity and speed equal to that of the innovative or original drug when administered orally. In this way, the goal of a bioequivalence study is to demonstrate through clinical trials that two medications containing the same drug, in the same dose, are equivalent in terms of quality and safety when used by a patient. However, some of them require additional studies that certify their effectiveness to be interchangeable.
In the case of people who decide to buy another medicine, identified as generic, that is not certified bioequivalent, they run the risk that it does not have the quality certification that guarantees that what they are receiving will be useful for the condition what is being treated.
Currently, 70 drugs have bioequivalence studies, among which are: antiallergics, muscle relaxants, anxiolytics, antidepressants and medications for the treatment of Parkinson’s, Alzheimer’s and AIDS. The main advantage of this initiative is to bring the best quality medicine to people, at an affordable cost. Also, a bioequivalence study is a tool that validates the effectiveness of medications.
The concept of EFG is to be a medicine that can be exchanged for another innovative medicine containing the same active ingredient in the same amount. A bioequivalence study is used as a tool to demonstrate that a generic medicine has the same therapeutic efficacy as the innovative reference medicine, so there is the possibility of alternative use of one or the other. In this way, new clinical trials are avoided, which are very complex and expensive to carry out, while resorting to much more affordable bioequivalence studies. These studies are mainly based on the belief that in the same human being, if the same active substance contained in two similar medicines is absorbed in the same amount and speed in blood, it will be in the place where exerts the action in a similar concentration then exerting a similar therapeutic effect. In these studies, pharmacokinetic data are assimilated to therapeutic data to establish equivalence.
To test this hypothesis it is enough to measure at different times the concentrations of an active principle in blood in different people for the generic formulation and the reference formulation and through statistical analysis to see if the kinetic behavior is similar and the bioequivalence can be established between both formulations.