Objective. To seek evidence that Timexon (BCD-063, glatiramer acetate, Biocad, Russia) and Copaxone-Teva (Teva Pharmaceuticals Ltd., Israel) have similar efficacies in patients with remitting multiple sclerosis. Materials and methods. A multicenter, double-blind, placebo-controlled, comparative, randomized, phase III study included 158 patients with confirmed diagnoses of remitting multiple sclerosis. Patients were randomized to the BCD-063, Copaxone-Teva, and placebo groups at a ratio of 2:2:1. Results and conclusions. Efficacy analysis at 48 weeks of treatment demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups in terms of MRI parameters or exacerbation frequency. Assessment of the primary endpoint (number of MRI-confirmed exacerbations per patient per year) showed that the mean number of exacerbations was 0.098361 (0.351422) in the BCD-063 group, 0.098361 (0.351422) in the Copaxone-Teva group, and 0.178571 (0.390021) in the placebo group. Assessments on the EDSS and MSFC also demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups. Both BCD-063 and Copaxone-Teva had favorable safety profiles. These data provide evidence of the therapeutic equivalence of BCD-063 (Biocad, Russia) and Copaxone-Teva, which is an important aspect for further introduction of the reproduced glatiramer acetate formulation into the treatment of multiple sclerosis.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
Morbidity of the Whole Population of Russia in 2014. Statistical Data from the Ministry of Health of the Russian Federation, https:/ www.rosminzdrav.ru/documents/9479-statisticheskaya-informatsiyaza-2014, acc. June 15, 2016.
E. I. Gusev, I. A. Zavalishin, and A. N. Boiko (eds.), Multiple Sclerosis. Clinical Guidelines, Real Time, Moscow (2011).
Approval package for application number: NDA 20-622/S-015. Center for Drug Evaluation and Research FDA, July 12, 2001, www. accessdata.fda.gov/drugsatfda_docs/nda/2001/020622_S015_COPAXONE_INJECTION_AP.pdf, acc. June 15, 2016.
Copaxone (glatiramer acetate for injection). New Drug Application for FDA NDA 20-622/S-015/S-015. 2001, www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf, acc. June 15, 2016.
Author information
Authors and Affiliations
Corresponding author
Additional information
Translated from Zhurnal Nevrologii i Psikhiatrii imeni S. S. Korsakova, Vol. 116, No. 10, Iss. 2, Multiple Sclerosis, pp. 61–67, October, 2016
Rights and permissions
About this article
Cite this article
Boiko, A.N., Lashch, N.Y., Sharanova, S.N. et al. A Comparative Placebo-Controlled Clinical Trial of the Efficacy and Safety of Glatiramer Acetate 20 mg in Patients with Remitting Multiple Sclerosis: First-Year Study Results. Neurosci Behav Physi 48, 351–357 (2018). https://doi.org/10.1007/s11055-018-0570-z
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11055-018-0570-z