Abbreviated New Drug Application (ANDA)
An ANDA is the abbreviated application under which a generic is approved by showing the same active ingredient and bioequivalence to a listed reference drug rather than by repeating clinical trials.
An abbreviated new drug application, authorised by section 505(j) following the Hatch-Waxman amendments of 1984, seeks approval for a copy of an already approved drug. The applicant does not repeat efficacy trials. It demonstrates sameness of active ingredient, strength, dosage form and route, and shows bioequivalence, conventionally by establishing that the 90 percent confidence interval for the ratio of AUC and Cmax against the reference falls within 80 to 125 percent.
For peptides the pathway is newer than most readers assume. FDA guidance issued in 2021 set out how an ANDA can reference a listed drug of recombinant origin when the proposed product is a highly purified synthetic peptide, naming glucagon, liraglutide, teriparatide, teduglutide and nesiritide among the candidates, and the first generic liraglutide was approved on that footing in late 2024. Which peptides are eligible turns on FDA's current guidance and Orange Book listings, both of which are revised.
The consequence of an ANDA is a genuinely interchangeable product. An approval carrying an AB therapeutic equivalence rating can be substituted at the counter under state law, which is not true of a 505(b)(2) product and not true of a biosimilar without an interchangeability designation. Price collapse follows substitution rather than approval.
The mistake is reading abbreviated as lightly reviewed. An ANDA carries full chemistry, manufacturing and controls review plus facility inspection, and for a synthetic peptide the impurity comparison is the demanding part, because a related-substance profile that differs from the reference raises immunogenicity questions no bioequivalence study answers. Research-grade peptide sold online has no such application behind it at all.