The article presents the results of safety fi ndings during international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. 158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: Timexon (glatiramer acetate, manufactured by JSC «BIOCAD», Russia), copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) and placebo, at a ratio of 2:2:1, respectively. At the second group 63 patients received Copaxone-Teva, after 48 weeks of therapy they received Timexon. Switching between therapy was not associated with adverse eff ect frequency. There was no clinically signifi cant diff erences in profi le and frequency of adverse eff ects between the groups of Copaxone-Teva and Timexon. Also, effi cacy analysis of therapy demonstrated no diff erences between timexone group and Copaxone-Teva group in both MRI parameters and frequency of relapses. The data obtained from the present study confi rm the equivalence in safety of Timexon (CJSC BIOCAD, Russia) and Copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.