The concept of bioequivalence
Two medicinal products are defined as bioequivalent when their bioavailability, i.e. the quantity of active ingredient that is released into the bloodstream, and the rate at which it is released are equivalent.
In practice, the concept of equivalent medicine is based on the assumption that, in the same subject, equal active substance plasma concentrations over time will produce an equal concentration of the substance at the site of action and, therefore, an equal therapeutic effect.
This is why the Agenzia Italiana del Farmaco (AIFA - Italian Medicines Agency) grants authorisation to produce and market an equivalent medicine on condition that the quality of the product is documented and that its bioequivalence to the original medicine is demonstrated.
In practice, the concept of equivalent medicine is based on the assumption that, in the same subject, equal active substance plasma concentrations over time will produce an equal concentration of the substance at the site of action and, therefore, an equal therapeutic effect.
This is why the Agenzia Italiana del Farmaco (AIFA - Italian Medicines Agency) grants authorisation to produce and market an equivalent medicine on condition that the quality of the product is documented and that its bioequivalence to the original medicine is demonstrated.
