Drugs

17 Revised Draft Guidances for Certain Generic Peptide Products

FDA has released 17 revised draft product-specific guidances (PSGs) for peptide products, which it touts as 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 says the documents are intended 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.”

The agency says the revised draft PSGs provide updated recommendations across five key areas for the 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.

Additionally, FDA is withdrawing the guidance “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (May 2021)” as it no longer reflects the agency’s current scientific thinking, noting that it plans to revise the guidance later this year.

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