update

FDA releases draft generic peptide ANDA guidances

FDA on July 28 published revised draft product‑specific guidances for generic peptide ANDAs, including liraglutide, glucagon, calcitonin salmon, shaping generic therapies.

On July 28, 2026, the FDA published 17 revised draft product-specific guidances for generic peptide ANDAs covering liraglutide, glucagon, calcitonin salmon, and others. The updates set new expectations for innate immune-response testing, impurity thresholds, higher-order structure assessment, and biological activity testing for recombinantly, synthetically, or semi-synthetically produced peptides ([fda.gov](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products?trk=public_post_comment-text&utm_source=openai)). The agency also withdrew its May 2021 guidance on highly purified synthetic peptide ANDAs, stating it no longer reflects current scientific thinking ([fda.gov](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products?trk=public_post_comment-text&utm_source=openai)).

Key takeaways

FDA published 17 revised draft product-specific guidances for generic peptide ANDAs on July 28, 2026.
The guidance updates address immune response testing, impurity limits, higher-order structure, and biological activity assessment.
These guidances may affect development of generic versions of peptide therapies used in women's health, including diabetes and osteoporosis.
FDA withdrew its May 2021 guidance on certain synthetic peptide ANDAs to align with current scientific thinking.

What did FDA update in the generic peptide ANDAs?

Why does this matter for women's health therapies?

The covered products have different indications, including diabetes, severe hypoglycemia, and osteoporosis. Their relevance depends on the specific product and patient population. Clearer ANDA standards could eventually lower barriers to generic peptide approval and expand affordable access. These remain draft guidelines. Actual effects on approval timelines and availability depend on clinical validation and final FDA adoption.

How should stakeholders respond to FDA's draft guidance?

Generic developers and clinicians should review how FDA's expectations for immune testing, impurity control, structure, and biological activity will shape drug comparability, especially for therapies important to women. FDA invites public comments before finalizing these guidances. Applicants can request PSG teleconferences or submit controlled correspondence to discuss implications for specific peptide ANDA programs (fda.gov).

Frequently asked questions

What are generic peptide ANDAs?

Generic peptide ANDAs are abbreviated new drug applications seeking approval for generic versions of peptide-based drugs by demonstrating therapeutic equivalence to listed brand-name products.

Which peptides are included in the FDA's revised draft guidances?

The 17 revised draft product-specific guidances include liraglutide, glucagon, calcitonin salmon, semaglutide, tirzepatide, teriparatide, and others ([fda.gov](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products?trk=public_post_comment-text&utm_source=openai)).

What updates do the generic peptide ANDAs guidance include?

The guidance adds updates on innate immune-response testing, impurity thresholds, higher-order structure assessment, and biological activity assessments essential for generic peptide development ([fda.gov](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products?trk=public_post_comment-text&utm_source=openai)).

Why did FDA withdraw the May 2021 peptide ANDA guidance?

FDA withdrew its May 2021 guidance on highly purified synthetic peptide ANDAs because it no longer reflects the agency's current scientific thinking ([fda.gov](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products?trk=public_post_comment-text&utm_source=openai)).

Can developers discuss these draft guidances with FDA?

Yes. FDA allows applicants to request PSG teleconferences or controlled correspondence to get agency feedback on implications of the draft guidance for specific peptide ANDA programs ([fda.gov](https://www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-development?utm_source=openai)). This article is for general information and is not medical advice. Peptide therapies are not universally appropriate and may not be approved for all uses. Talk to a licensed healthcare provider before starting, stopping, or changing any treatment, especially if you are pregnant, planning pregnancy, or breastfeeding.

Sources

Primary records

FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products | FDA
peer reviewed article
Product-Specific Guidances for Generic Drug Development | FDA
peer reviewed article

Published 2026-10-23

Medical disclaimer: Her Health Peptides publishes educational, source-linked summaries. We do not provide individualized medical advice, diagnosis, or treatment recommendations. Always talk with a licensed clinician about your specific situation, especially if you are pregnant, breastfeeding, planning pregnancy, or taking other medicines.

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