The Ministry of Health of the Russian Federation registered the domestic bioanalogue bevacizumab Designed and built by the Russian company BIOCAD. The drug bevacizumab is used in cancer therapy, and among the most expensive drugs purchased by the state under the federal program providing the necessary drugs (ONLS). This is the first in the history of bioanalogue bevacizumab.
According to preliminary estimates, the domestic bioanalogue should take a significant market share to foreign competitors, and Russian patients will be able to get it in the first quarter of 2016.
In 2014 market purchases bevacizumab budget amounted to 3.2 billion rubles. This year, market volume in value terms will remain at a similar level.
For many years, the only manufacturer of the drug bevacizumab was a Swiss company F. Hoffmann-La Roche Ltd. First bioanalogue bevacizumab developed, manufactured and registered in November of this year, the Russian company BIOCAD, compete with foreign drug. It is planned that the Russian medicine will cost up to 30% cheaper foreign drugs that will provide the desired drug an increasing number of Russian patients.
Based on the results of clinical trials, it has been proven effective biosimilars bevacizumab on key indicators of pharmacokinetics, efficacy, safety and immunogenicity. Phase III study was completed in December 2014. Note that the profile of the effectiveness of the drug companies BIOCAD showed no differences from the original drug. The overall rate of response to therapy, which is the main criterion for assessing the effectiveness of biosimilars, the Russian drug was not lower than that of the original drug.
In studies of bevacizumab biosimilars was attended by major medical centers in Russia, Belarus and Ukraine. Among them: the RCRC. NN Blokhin, FGBU Oncology Institute. NN Petrova Russian Ministry of Health, FGBVOU VPO Naval Academy. CM. Kirov Russian Defense Ministry Medical University, St. Petersburg State Medical University named after academician IP Pavlova, Russian Ministry of Health and others.
"Bevacizumab - a drug, which are in great need of our patients with advanced disease. The fact that the Russian company was able to make a drug that is on all of its characteristics equivalent to the foreign - is a major breakthrough and success of the Russian farm. But most importantly - the establishment of the Russian biosimilars - thousands of life extension "- says Sergey Orlov, a leading researcher at the Department of Oncology Medical University" St. Petersburg State Medical University named after academician IP Pavlova "Health Ministry.
More information about the clinical trial is available at the international registry of clinical trials under the number NCT01763645.
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