FDA Issues 55 New Bioequivalence Guidances for Generics

FDA published 55 product-specific guidances for generic drug developers on 24 August 2026 — 24 new and 31 revised — laying out the bioequivalence studies the agency wants to see before it will approve an Abbreviated New Drug Application (ANDA) for each listed product. More than 30 of the 55 cover drugs with no currently approved generic at all.

What a product-specific guidance actually does

A PSG is FDA's recommendation — not a binding rule — on how a generic sponsor should demonstrate bioequivalence to a specific reference listed drug: what kind of study (in vivo pharmacokinetic, in vitro dissolution, comparative clinical endpoint), what population, what analytes, what statistical approach. The agency has issued PSGs product by product since 2007 under the authority cited in this notice's docket number, and updates the list continually as new reference products enter the market, as science evolves, or as FDA revises its thinking on an existing recommendation. A sponsor is free to propose a different approach with justification, but a PSG is the fastest path to a predictable review.

Why the first-PSG products matter most

The single most consequential category in any PSG batch is the set of products that have never had a PSG before — FDA flagged more than 30 of this batch's 55 as falling with no ANDA currently approved. For a generic developer, the absence of a PSG is a standing barrier: without an FDA-endorsed study design, a sponsor either guesses at what the agency will accept or requests a controlled correspondence, both of which add years to a development timeline. A first PSG for a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor used in non-cystic fibrosis bronchiectasis, and one for a PARP inhibitor tied to biomarker-driven oncology, tells the generic industry FDA now has a settled bioequivalence approach for those molecules — the practical starting gun for competitors to begin designing their own BE studies.

The revisions are not just paperwork

Thirty-one of the 55 guidances are revisions to existing PSGs, and revisions can change a development program already underway. FDA's updated ferumoxytol injection guidance adds new bioequivalence recommendations alongside additional physicochemical characterization tests — a heavier analytical burden for an iron-replacement therapy already on generic sponsors' target lists. A new PSG for topical benzoyl peroxide/tretinoin cream, by contrast, lowers a barrier: it recommends in vitro bioequivalence testing as an alternative to a comparative clinical endpoint study, a substantially cheaper and faster pathway if a sponsor can meet the in vitro criteria. Reading only the new-PSG count understates how much this batch moves for generic teams already mid-program on a revised product.