What is the regulatory pathway for approval of generic drugs based on bioequivalence to a reference product?

• A. New Drug Application (NDA)
• B. Abbreviated New Drug Application (ANDA)
• C. Biologics License Application (BLA)
• D. Investigational New Drug Application (IND)

Answer: (B)

The key pathway for generic drugs is the Abbreviated New Drug Application, which relies on demonstrating bioequivalence to a reference product. Bioequivalence means the generic’s rate and extent of absorption are not significantly different from the brand-name product when given at the same dose under the same conditions, so safety and efficacy are considered the same without duplicating trials. An ANDA submission requires pharmaceutical equivalence (same active ingredient, strength, dosage form, and route) and demonstrated bioequivalence, along with manufacturing quality and labeling that match the reference product. If approved, the generic can enter the market without performing new pivotal efficacy trials, since the reference product already established safety and efficacy. Other pathways exist for different types of products: a traditional New Drug Application is for a new active ingredient or new indication; a Biologics License Application is for biologic products; an Investigational New Drug Application is the sponsor’s request to begin clinical studies.