Safety of Use of Russian Biosimilars of Interferon Beta-1b in the Treatment of Multiple Sclerosis: a Meta-analysis of Original Studies

• Published in: Bezopasnostʹ i risk farmakoterapii (Online) Vol. 7; no. 2; pp. 93 - 98
• Main Authors: Gudz, D. O., Krasnov, A. E., Mamleev, R. N., Kagirov, R. K., Maximov, M. L.
• Format: Journal Article
• Language: English; Russian
• Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products 16-06-2019
• Subjects: adverse drug reactions; biosimilars; interferon beta-1b; meta-analysis; multiple sclerosis; therapeutic equivalence
• ISSN: 2312-7821; 2619-1164
• DOI: 10.30895/2312-7821-2019-7-2-93-98

Presently, an active search for  modern drugs for  the  treatment of multiple sclerosis is ongoing. Since  the  treatment with original drugs is expensive, therefore, the  development of local biosimilars is underway, which at a lower  cost should be effective and safe  as original ones. The aim of the study  is to compare the  safety of foreign preparations of interferon beta-1b (Betaferon and  Ekstavia) with Russian biosimilars (Ronbetal®, Infibeta®) in the  treatment of multiple sclerosis to ensure the  possibility of import substitution. In the  present study the  safety of domestic interferon beta-1b biosimilars in the  treatment of multiple sclerosis was studied using a meta-analysis method. There were 3 studies included in the meta-analysis. A total of 778 people participated in the  study. The average age of the  subjects was 35.92 ± 9.57 years. The main inclusion criteria were a reliable diagnosis of remittent or secondary progressive multiple sclerosis with exacerbations, an  EDSS score  less  than 5.5. The  subjects were  divided into 2 groups: the first group received therapy with the  Russian biosimilars of interferon beta-1b (Ronbetal®, Infibeta®), the  second — the  foreign ones (Betaferon, Extavia) in therapeutic doses. The duration of therapy was at least 6 weeks. Results. A meta-analysis of three studies showed the  following data: the difference in the frequency of local complications such as hyperemia in patients who received Russian and  foreign interferon beta-1b analogues statistically insignificant, the  relative risk is 1.243 (p > 0.05). No statistically significant differences in the frequency of influenza-like syndrome were  also  detected: the  relative risk is 1.459 (p > 0.05). Conclusion. This  study has increased the power of the evidence base in the application of Russian biosimilars. The conducted meta-analysis showed the absence of a statistically significant difference in the incidence of such side effects as the  injection site hyperemia and the  influenza-like syndrome in domestic biosimilars of interferon beta-1b compared with foreign ones.