Immediate side effects study of locally manufactured filgrastim («Leucostim®») in neutropenia treatment and prophylactics in children

Abstract

Introduction of biosimilars in clinical practice results in substantial reduction of direct medical costs. However, limited data concerning safety and tolerance of biosimilars exist, especially in children. We conducted double blind randomized trial comparing immediate tolerance of locally manufactured filgrastim (LeucostimR, “Biocad”, Russia) with original formulation (“Neupogen”, “Roche”, Switzerland) in children with various hematologic and oncologic diseases. Ten patients (4 F; 6 M) with a median age of 9.5 y (range 5—16 y) in whom G-CSF was indicated either by protocol or clinically were included into the study. All patients were scheduled to receive both formulations of G-CSF in order determined by randomization with permuted blocks. Pain was assessed with visual analog scale, ranging sensation of pain from 0 to 10 points. There were 41 injections of LeucostimR and 39 of Neupogen, and а median number of points attributed was 1.134 (0—10), and 1.661 (0—9) respectively (p=0,669). Intrapatient pain scores were quite consistent and did not differ by more than 1 point between any two injections. Other immediate toxicities were negligible or inexistent. Our study clearly demonstrates that both formulation of filgrastim are equally well tolerated.