Interferon beta-1b biosimilar(Biocad Medical, Inc.)

Authors have followed up 230 patients with multiple sclerosis treated with disease modifying drugs (DMD) using the data of the Multiple sclerosis register of the Yaroslavl oblast during 2009-2011. Original drugs and their generics registered in Russia are used. Patients received interferon-beta 1a for intramuscular introduction (avonex - 3.0%), interferon-beta 1a for hypodermic injection (rebif - 19.2%, genfakson - 8.5%), interferon-beta 1b (betaferon - 16.5%, extavia - 18.2%, ronbetal - 18.0%), glatimer acetate (copaxone - 16.7%). Adverse effects were recorded and subjective tolerability of the drug by the patient was assessed. Statistically significant differences in the safety profile between some bioanalogues and original DMD were identified. This finding suggests that effects of different DMD should be studied in depth in clinical and post marketing trials.

The results of using ronbetal, the Russian biosimilar of interferon-beta 1b, in the treatment of multiple sclerosis (MS) are presented. The study included outpatients followed up from February 2008 to March 2012. All patients were assessed neurologically with additional evaluation using the EDSS; a number of exacerbations and their outcomes, disease progression, tolerability of the drug were recorded. No significant differences in the efficacy of ronbetal and betaferon were found. The frequency of exacerbations and MS progression were comparable for both drugs. The same was with the tolerability, with the exception of higher frequency of the flu-like syndrome at the beginning of treatment with ronbetal. A single-step substitution of betaferon for ronbetal often caused the discontinuation of treatment by patients because they were not fully informed about the new drug, need to use a new dose titration scheme and were anxious about side-effects.