JIST

Abstract

The requirement of nonclinical studies for the safety evaluation of biotechnology-derived therapeutic drugs using different animal species often depends on the characteristics of the products. Moreover, in practice, the requirement of different types/number of nonclinical studies depends on the regulations and system of national/international drug approval authorities.

This review assessed twenty-four repeat dose toxicology studies of different therapeutic proteins conducted using two different relevant species to determine whether there was any new findings/information on adverse characteristics of therapeutic proteins towards the clinical safe practices and/or whether one species could serve the safety purposes. With this vision, the strategy involved here was the assessment of findings of twenty-four repeated dose toxicity studies conducted in two species for different biosimilar proteins of Reliance Life Sciences Pvt. Ltd., Navi Mumbai.

The critical evaluation of findings of the different therapeutic proteins depicted similar target organs of toxicity and/or secondary responses owing to the exaggerated pharmacological activity in both the species with a difference of dosage levels in a few cases.

This review addressed the significance/implications of these findings at the cost of sacrifice of a second species, and further discussed future options to reduce animal use in biological therapies safety evaluation programs.