SAFETY STUDY OF ROMIPLOSTIM BIOSIMILAR

Idiopathic thrombocytopenic purpura is a chronic autoimmune hematological disease caused by an increased destruction of platelets and associated thrombocytopenia, for the treatment which imported drug romiplostim used. Сreation biosimilar provides reduction in cost therapy access to more patients. The aim study was compare safety indicators reference its vivo vitro. Materials methods. In vitro study, model “complement-dependent cytotoxicity” induced complement formed on 32D hTPOR clone 63-cell line, followed cell viability measurement with CellTitter Glo ® kit . An part carried out Javanese macaque monkeys (Macaca fascicularis). During experiment, clinical condition, mortality, appetite animals, their body weight, temperature, respiratory rate were assessed, parameters blood urine animals also monitored, hemostasis additionally measured. Results. original GP40141 compared terms EC50 values. indicatirs did not show complement-dependent cytotoxicity. According results, no deviations recorded status feed intake, lethality fixed groups either. For all studied (body weight rate, urinalysis, biochemical tests, coagulation hemostasis), romiplostim, when administered at doses equivalent 10 toxic (TDs), had comparable effects. Conclusion. comparison performance both , showed similar results.