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Background Biosimilars are biologic medical products and receiving increasing attention in the pharmaceutical field.Cynomolgus monkeys are used in preclinical studies for biosimilars due to physiological and genetic similarities to humans.We aimed to develop and validate an ELISA for the determination of a humanized lgG type monoclonal antibody(biosimilar)that binds to interlukin 6 receptor in cynomolgus monkeys Methods The ELISA was developed with both commercially available reagents and sponsor-made reagents.