FDA issues revised draft guidance for generic peptide products
FDA released 17 revised draft product‑specific guidances for generic peptide products—including calcitonin, glucagon, and liraglutide—to advance regulatory clarity.
Key Takeaways
- FDA issued 17 revised draft product-specific guidances covering key peptides.
- Guidances update criteria on ANDA submissions, impurity thresholds, immune testing, higher-order structure, and biological activity.
- FDA withdrew its May 2021 synthetic peptide ANDA guidance to reflect current scientific thinking.
- These draft PSGs aim to reduce uncertainty for developers pursuing generic peptide approvals.
What are generic peptide PSGs?
Generic peptide PSGs are FDA’s current thinking on how to develop generic versions of peptide drugs such as calcitonin, glucagon, liraglutide, and others. They describe recommended approaches for abbreviated new drug applications (ANDAs), impurity testing, immune response evaluation, higher-order structure, and biological activity assessments, among other areas link(fda.gov).
Which peptide products are included in the revised draft guidances?
The FDA issued 17 revised draft product-specific guidances covering peptides including calcitonin salmon (CALCIMAR, MIACALCIN), dasiglucagon hydrochloride (ZEGALOGUE), multiple glucagon products (BAQSIMI, GLUCAGON, GVOKE), liraglutide formulations (VICTOZA, SAXENDA), pegcetacoplan (SYFOVRE, EMPAVELI), semaglutide (OZEMPIC, WEGOVY), teriparatide products, tirzepatide (MOUNJARO, ZEPBOUND), and vosoritide link(fda.gov).
Why did FDA withdraw its May 2021 peptide ANDA guidance?
FDA withdrew its May 2021 guidance for ANDAs of highly purified synthetic peptide drugs referencing rDNA-origin listed drugs because it no longer aligned with the agency’s current scientific thinking. The revised 2026 draft PSGs reflect updated standards, especially across impurity thresholds, innate immune response testing, and structure-activity assessments link(fda.gov).
How will these guidances affect generic development planning?
These draft PSGs offer developers clearer benchmarks for designing ANDA packages. Applicants preparing filings for complex peptides will face less scientific uncertainty. FDA will consider comments before finalizing the guidances, and developers may request teleconferences once they are live to align development plans with FDA expectations link(fda.gov).
FAQ
What are generic peptide PSGs?
Generic peptide PSGs are FDA’s draft recommendations on how to develop generic versions of peptide drugs, including expectations for ANDA submissions, impurity limits, immune testing, higher-order structure, and biological activity assessments.
How many revised draft product-specific guidances were released?
FDA released 17 revised draft product-specific guidances for generic peptide products.
Which peptide drugs do these guidances cover?
They cover a range of peptides including calcitonin salmon, glucagon products, liraglutide, semaglutide, teriparatide, tirzepatide, pegcetacoplan, dasiglucagon hydrochloride, and vosoritide.
Did FDA withdraw any previous guidance?
Yes. FDA withdrew its May 2021 guidance on ANDAs for certain highly purified synthetic peptide products of rDNA origin, stating it no longer reflects current scientific thinking.
How can applicants respond to these draft guidance documents?
Applicants can submit comments to the public docket. Once guidances are live, they may request teleconferences to discuss alignment of their ANDA development strategies with FDA’s recommendations.
Note: This article is for general information and is not medical advice. Talk to a licensed clinician before using any peptide product.