The regulatory pathway for seeking FDA approval of a generic drug product. An ANDA applicant must demonstrate that its product is bioequivalent to an already-approved reference drug—same active ingredient, dosage form, strength, route of administration, and conditions of use—without repeating the full clinical trial program that the original drug required.

The ANDA pathway is relevant to the peptide space because as patents expire on FDA-approved peptide drugs, generic versions can enter the market. However, complex peptides and biologics often do not qualify for standard ANDA approval and instead require a Biologics License Application (BLA) with a biosimilar pathway under the Biologics Price Competition and Innovation Act (BPCIA). This distinction matters for compounds like semaglutide and tirzepatide, where the path to lower-cost alternatives is more complex than traditional generic drug entry.