How does bioequivalence evaluation influence the regulatory approval of generic drugs?

Bioequivalence evaluation is critical for the regulatory approval of generic drugs as it ensures that the generic version is therapeutically equivalent to the reference listed drug. By demonstrating that the generic has similar bioavailability and pharmacokinetics as the original, it guarantees comparable efficacy and safety. This evaluation, guided by regulations like 21 CFR 320.24, is essential for confirming the generic’s clinical performance, thereby playing a vital role in obtaining regulatory approval.