FDA Publishes 17 Revised Draft Product-Specific Guidances for Generic Peptide Products
On July 28, 2026, the FDA published 17 revised draft product-specific guidances, known as PSGs, for peptide products. The FDA statement lists products including semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro, Zepbound), liraglutide, glucagon, teriparatide, pegcetacoplan, and vosoritide.
Product-specific guidances are the FDA roadmap for developers who want to show that a proposed generic matches a reference product. They are recommendations for future applications, not approvals of any product.
The FDA said the revisions update its recommendations across five areas. Those areas are ANDA submission of recombinant, synthetic, or semi-synthetic peptides, innate immune response testing, impurity thresholds, higher-order structure, and biological activity.
The agency also said it was withdrawing its May 2021 synthetic peptide ANDA guidance. Taken together, the July 28 action replaces an older general framework with updated, product-by-product draft recommendations.
The limit of the action is important. These are draft guidances for generic development, and no generic semaglutide or tirzepatide was approved by this action. A guidance publication changes what developers are told to submit; it does not change what is approved, and approval, when it comes, will belong to a specific generic product and its labeled indication.
Sources
- FDA - FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products
- FDA GovDelivery bulletin - FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development (revised complex peptide PSGs)