The FDA issued draft recommendations allowing biopharma companies to reduce or omit nonhuman primate testing for certain monoclonal antibodies during development. The guidance offers pathways to rely on alternative in vitro and in silico approaches or use other animal models when scientific justification supports that approach. The draft reflects regulators’ willingness to modernize toxicology expectations where mechanistic understanding and predictive assays reduce reliance on primates, which could lower costs and speed early-phase human trials. Agencies signaled the policy aims to keep US biopharma competitive with international counterparts advancing nonanimal strategies. Sponsors will need to map robust justification and comparative data packages to use the new pathways; the guidance will also spur investment in predictive platforms and regulatory science supporting antibody safety without routine primate studies.