Comment Period Closes September 28 on FDA's 17 Revised Draft Guidances for Generic Peptides, Including Semaglutide and Tirzepatide
On July 28, 2026, the FDA published 17 revised draft product-specific guidances for generic versions of peptide drugs, including semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro, Zepbound), liraglutide, glucagon, dasiglucagon, calcitonin salmon, pegcetacoplan, teriparatide, and vosoritide. The recommendations cover how sponsors should submit recombinant, synthetic, or semi-synthetic peptides as ANDAs, innate immune response testing, impurity thresholds, higher order structure assessment, and biological activity assessment. The agency also withdrew its May 2021 guidance on ANDAs for highly purified synthetic peptides that reference drugs of rDNA origin, saying it no longer reflects current scientific thinking. The public comment window closes on September 28, 2026.