OBJECTIVEto study safety and efficacy of the biosimilars of disease-modifying drugs (DMDs) in the prospective nonrandomized open long-term study of patients with multiple sclerosis in the Yaroslavl oblast (an Yaroslavl' cohort).MATERIAL AND METHODSThe study included 203 patients treated with DMD biosimilarsduring 30 months according to the instruction for using. The efficacy was assessed by the relapse frequencychanges in EDSS scores, changes of lesions on MRI T2-weighted images (T2-WI). The safety was assessed by the determination of the percentage of patients with side-effects due to the treatment. Results at baseline and month 30 visit were compared.RESULTSThere was a significant decrease in the frequency of relapses in patients treated with biosimilars compared to baseline (cinnovex by 0.03, genfaxon by 0.29, ronbetal/interferon by 0.13, infibeta by 0.36). For all biosimilars, with the exception of infibeta,EDSS scores significantly increased (cinnovex +0.31, genfaxon +0.38, ronbetal/interferon +0.66, infibeta +0.26). MRI results revealed an increase in the number of lesions in patients treated with cinnovex (+16.6%), genfaxon (+14.4%) and ronbetal (+10.6%) and a decrease of lesions on T2-WI in patients treated with infibeta (-14.5%). The most marked generalized reasponses were in the cinnovex group (flu-like syndrome - 66% of the patients), local reactions were most marked in the genfaxon group (82%).CONCLUSIONThe differences between some biosimilars and original DMDs in the safety profile and efficacy suggest that attention should be drawn to the thorough study of drug effects in clinical trilas and postmarketing studiesincluding registers of patients treated with DMDs managed independently from pharmaceutical companies.

01 Jan 2012·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

[Side-effects of the treatment with disease modifying drugs in patients with multiple sclerosis: an analysis of register data in the Yaroslavl region].

Article

Author: Shipova, E G ; Baranova, N S ; Stepanov, I O ; Kasatkin, D S ; Spirin, N N

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.

01 Jan 2012·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

[Biosimilar of interferon-beta 1b in the treatment of multiple sclerosis and the own experience in the use of ronbetal].

Review

Author: Granatov, E V ; Khaĭbullin, T I ; Akhmedova, G M ; Babicheva, N N ; Khabirov, F A ; Aver'ianova, L A

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.

100 Deals associated with Interferon beta-1b biosimilar(Biocad Medical, Inc.)

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KEGG	Wiki	ATC	Drug Bank
-	-	L03AB08	DB00068

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Indication	Country/Location	Organization	Date
Multiple Sclerosis	-	Biocad Medical, Inc.	-

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