FDA Publishes Revised Draft Bioequivalence Guidances Covering Semaglutide, Liraglutide, and Tirzepatide
On July 29, 2026, FDA announced the availability of revised draft product-specific guidances. The list includes semaglutide, liraglutide, and tirzepatide, each noted as covering "multiple reference listed drugs." These guidances give companies FDA’s recommendations on the design of bioequivalence studies used to support abbreviated new drug applications — the route by which generic versions of an approved drug are reviewed. FDA is accepting comments through September 28, 2026.
What this meansProduct-specific guidance is an early, procedural step on the generic pathway — not an approval, and not a timeline. It’s worth tracking because approved generics, whenever they arrive, would be reviewed by FDA for safety, effectiveness, and quality in a way compounded versions are not.
Source: FDA original ↗