The FDA has published 17 revised draft product-specific guidances for peptide products, updating its recommendations for the development and assessment of certain generic peptide drugs.
The revised draft guidances address the following peptide products, according to a July 28 agency news release:
- Calcitonin salmon (Calcimar)
- Calcitonin salmon (Miacalcin)
- Dasiglucagon hydrochloride (Zegalogue)
- Glucagon (Baqsimi)
- Glucagon (Glucagon)
- Glucagon (Gvoke)
- Liraglutide (Victoza)
- Liraglutide (Saxenda)
- Pegcetacoplan (Syfovre)
- Pegcetacoplan (Empaveli)
- Semaglutide (Ozempic)
- Semaglutide (Wegovy)
- Teriparatide (Forteo)
- Teriparatide (Teriparatide)
- Tirzepatide (Mounjaro)
- Tirzepatide (Zepbound)
- Vosoritide (Voxzogo)
The drugs are used to treat conditions including obesity, Type 2 diabetes, osteoporosis and macular degeneration.
The FDA said the updates provide recommendations in five areas: submission of recombinantly, synthetically or semi-synthetically produced peptides as abbreviated new drug applications, innate immune response testing, impurity thresholds, higher order structure assessment and biological activity assessment.
The FDA also said it is withdrawing its May 2021 guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, because it no longer reflects the agency’s current scientific thinking. The Center for Drug Evaluation and Research plans to revise that guidance this year.
The update comes days after the FDA’s Pharmacy Compounding Advisory Committee voted to recommend adding several wellness peptides, including BPC-157, KPV and TB-500, to the agency’s Section 503A Bulk Drug Substances List, despite objections from FDA staff scientists over insufficient safety and effectiveness data.
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