What is "bioequivalence"?

Bioequivalence specifically refers to the relationship between two formulations of the same drug that are expected to have similar bioavailability, meaning they release the same active ingredient into the bloodstream at a comparable rate and extent. This concept is crucial in regulatory settings, particularly when evaluating generic drugs against their brand-name counterparts. For a generic drug to be approved, it must demonstrate bioequivalence to the reference drug, ensuring that patients receive the same therapeutic effect as the original medication.

In this context, the focus is on how quickly and to what extent the active ingredient from each formulation reaches systemic circulation, which directly impacts the drug's efficacy and safety profile. Therefore, understanding bioequivalence is essential for regulatory professionals involved in the drug evaluation and approval process, enabling them to assess the therapeutic interchangeability of different formulations.