FDA CDER analysis of non-human primate (NHP) data in monoclonal antibody (mAb) development to support the streamlining of nonclinical safety studies

2026-05-04

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Yanning Hao

Nakissa Sadrieh *

DOI：10.1016/j.yrtph.2026.106124

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Abstract

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• Long-term NHP toxicity studies were reviewed for 52 FDA-approved mAbs (2020–2025). • Long-term studies rarely identified new safety findings beyond shorter studies. • Most additional findings reflected target pharmacology or species-specific immunogenicity. • Only one long-term study influenced regulatory risk management via clinical monitoring. • Findings provide descriptive support for recent FDA guidance on streamlined mAbs nonclinical safety studies.

Keywords:

monoclonal antibodies

non-human primate toxicity studies

regulatory guidance

safety assessment

drug development

FDA CDER analysis of non-human primate (NHP) data in monoclonal antibody (mAb) development to support the streamlining of nonclinical safety studies

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