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FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products
Today, the Food and Drug Administration published 17 revised draft product-specific guidances (PSGs) for peptide products, marking a significant advancement in the agency’s scientific and regulatory approach to generic peptide drug assessment. The revised draft PSGs address the following peptide products:
- Calcitonin salmon (CALCIMAR, NDA 017769)
- Calcitonin salmon (MIACALCIN, NDA 017808)
- Dasiglucagon hydrochloride (ZEGALOGUE, NDA 214231)
- Glucagon (BAQSIMI, NDA 210134)
- Glucagon (GLUCAGON, NDA 020928)
- Glucagon (GVOKE, NDA 212097)
- Liraglutide (VICTOZA, NDA 022341)
- Liraglutide (SAXENDA, NDA 206321)
- Pegcetacoplan (SYFOVRE, NDA 217171)
- Pegcetacoplan (EMPAVELI, NDA 215014)
- Semaglutide (OZEMPIC, NDA 209637)
- Semaglutide (WEGOVY, NDA 215256)
- Teriparatide (FORTEO, NDA 021318)
- Teriparatide (TERIPARATIDE, NDA 218771)
- Tirzepatide (MOUNJARO, NDA 215866)
- Tirzepatide (ZEPBOUND, NDA 217806)
- Vosoritide (VOXZOGO, NDA 214938)
FDA publishes PSGs to help facilitate generic drug development, streamline abbreviated new drug application (ANDA) assessment, and support greater access to generic drugs that are as safe and effective as their brand-name counterparts and meet the same high-quality standards. Improving access to generic medicines supports the agency’s mission of advancing public health, as outlined in FDA’s Drug Competition Action Plan. Accelerating the development and approval of generic drugs also advances the goals of the President’s Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First.
These revised draft PSGs provide FDA’s updated recommendations across five key areas for these peptide drug products: submission of recombinantly, synthetically, or semi-synthetically produced peptides as ANDAs, innate immune response testing, impurity thresholds, higher order structure assessment, and biological activity assessment. These PSGs address drugs that include, but are not limited to, those used to manage obesity and treat type 2 diabetes, osteoporosis, and macular degeneration.
These updates reflect years of extensive regulatory experience, harmonization with global regulatory standards, and incorporation of the latest scientific evidence, representing a meaningful evolution in how FDA assesses generic peptide drug products and helping ensure that ANDAs for these products meet the regulatory requirements for approval.
The recommendations set forth in these draft PSGs may also be applicable to the development of other generic peptide drug products. In those instances, applicants are encouraged to contact the Office of Generic Drugs (OGD) via a formal meeting request or in a controlled correspondence.
When finalized, these PSGs will describe the agency's current thinking and recommendations on how to develop generic drug products therapeutically equivalent to these peptide products. FDA considers all comments submitted to the public docket before finalizing PSGs.
Today, FDA is also withdrawing the guidance for industry ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (May 2021) as it no longer reflects FDA’s current scientific thinking. As noted in the Center for Drug Evaluation and Research 2026 Guidance Agenda, FDA plans to revise the guidance this year.
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