Initial assays for the characterization of a biosimilar anti-PD-1 monoclonal antibody to Nivolumab

Introduction: According to the World Health Organization (WHO), cancer is the second leading cause of death in world’s population. In Brazil, it’s expected the occurrence of 600.000 new cases for year for the biennium 2018-2019. The immune system acts controlling and eradicating the disease. However, in malignancy scenario, several mechanisms of immune suppression may be present, reducing the antitumor immunity of the host. Thus, antibody therapy against immunological checkpoints, such as programmed cell death 1 (PD-1), has been shown to be successful in reversing immunosuppression. Biosimilars are biological medicines that have the same safety and efficacy as reference medicines. The substitution of reference products for biosimilars may increase patients’ access to these drugs as well as reduce public health expenditures.