Natalizumab had no adverse effects on the general health, survival, development, or immunological structure and function of infants born to dams treated with natalizumab during pregnancy.

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Developmental and reproductive toxicity (DART) evaluation of biopharmaceuticals frequently necessitates the use of nonhuman primate models (NHPs) owing to species specificity. NHPs offer several advantages over rodents and rabbits with regard to DART because of similarity to human. This article provides a state‐of‐the‐art account on the feasibility and limitations of using NHPs for DART evaluation in the context of preclinical development of biopharmaceuticals.