Open AccessSAFETY ASPECTS WITHOUT LOSS OF EFFECTIVENESS IN THE SWITCH OF PATIENTS WITH MULTIPLE SCLEROSIS FROM THE ORIGINAL DRUG GLATIRAMER ACETATE COPAXONE-TEVA ON THE BIOSIMILAR TIMEXON
Author(s) -
T. O. Simaniv,
M. N. Zakharova,
Alexey Boyko,
N. Yu. Lashch,
С. В. Котов,
Ф. А. Хабиров,
Т И Хайбуллин,
D V Sazonov,
A. V. Yarmoschuk,
Л. А. Бабенко,
Yu. V. Trinitatsky
Publication year - 2019
Publication title -
rossijskij nevrologičeskij žurnal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.104
H-Index - 4
eISSN - 2686-7192
pISSN - 2658-7947
DOI - 10.30629/2658-7947-2019-24-4-44-51
Subject(s) - glatiramer acetate , biosimilar , medicine , adverse effect , placebo , clinical trial , relapsing remitting , multiple sclerosis , pharmacology , physical therapy , immunology , alternative medicine , pathology
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.