FDA Finalizes Bioequivalence Guidance for ANDA Submissions with Pharmacokinetic Endpoints

Generic drug manufacturers submitting ANDAs now have a finalized regulatory framework governing bioequivalence study design and pharmacokinetic endpoint requirements, following FDA's Center for Drug Evaluation and Research (CDER) publication of the final guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.

The guidance, issued under docket number FDA-2013-D-1464, applies to applicants incorporating BE data into original ANDAs, ANDA amendments, and ANDA supplements. It consolidates recommendations on how to satisfy the bioequivalence requirements set out in the Federal Food, Drug, and Cosmetic Act and applicable FDA regulations, providing a single reference point for study planning, protocol design, and submission strategy.

For regulatory affairs leads and BE study sponsors, the document finalizes a draft that has been in circulation since August 23, 2021. Any BE protocols developed against that draft should now be reconciled with the final version before submission. ANDA supplements and amendments already in preparation are equally in scope, making a protocol-level review a near-term priority for teams with active dossiers.

The guidance is consistent with the agency's broader effort to standardize PK-endpoint-based BE methodology across the generic drug program. Manufacturers operating under 21 CFR Part 320, which governs bioavailability and bioequivalence requirements, should treat this finalization as a checkpoint for aligning internal SOPs, study protocols, and submission templates with the current agency position.

Comments on the guidance remain open and may be submitted online or in writing to FDA's Dockets Management office at any time, per 21 CFR 10.115(g)(5), referencing docket number FDA-2013-D-1464.

Reconciliation of existing BE protocols against the finalized guidance will be a measurable compliance checkpoint for any ANDA sponsor with studies currently in design or under IND-exempt conduct.

Source: FDA Center for Drug Evaluation and Research via FDA.gov Guidance Documents, May 28, 2026.