Reproductive/developmental toxicity studies biopharmaceuticals

Review of the reproductive/developmental toxicity studies that have been conducted in support of the approved biopharmaceuticals have shown that historically a flexible case-by-case approach has been applied. For biopharmaceuticals that cross-react only with nonhuman primates a limited reproductive toxicity testing strategy has been employed based on the patient population, the indication, and the proposed clinical use. The studies that have been performed have been sufficient to inform the patient populations of potential risk to the fetus. 

Reproductive and Developmental Toxicity Studies The requirement for reproductive and developmental toxicity studies depends on the clinical indication and intended patient population. For example, when (1) no relevant animal species exists, (2) a biopharmaceutical is not used for pregnant women or women of child-bearing potential (3) there is a structurally comparable natural biopharmaceutical for which there is much experience in clinical practice, or (4) a biopharmaceutical is indicated for patients with minimal childbearing potential and indicated for those with serious diseases, reproductive, and developmental toxicity studies could be obviated. 

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