FDA finalizes guidance on therapeutic equivalence evaluations for ANDAs

The U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applications (ANDAs).

TE codes, which are listed in the agency’s Orange Book, signal whether a generic product is bioequivalent to a reference‑listed drug.

The new guidance outlines the criteria and procedures the FDA will use to assess TE and to assign the appropriate code, aiming to bring greater consistency to the process.

Generic manufacturers and regulators are expected to use the clarified framework when reviewing ANDA submissions and updating the Orange Book.