The Ministry of Health of the Russian Federation has registered a bioanalogue of the infliximab developed by the Russian company BIOCAD on the basis of clinical trials, third phase of which has been carried out by scientists of the Belgorod state university
Clinical trials of the first Russian medicine on the basis of monoclonal antibodies - an infliximab (VSD-055) have been carried out by the staff of BelSU scientific research institute of pharmacology of live systems on the basis of rheumatologic office of the Prelate Ioasaf Belgorod clinical hospital. Researches were conducted under the leadership of the doctor of medical sciences, professor of pharmacology and clinical pharmacology department, the senior research associate of BelSU Scientific Research Pharmacological of living systems Institute Tatyana Pokrovskaya with the assistance of the manager of office Lyudmila Masneva.
As Tatyana Pokrovskaya has reported, clinical trials of an infliximab have been conducted in full accordance with the European recommendations about studying of bioanalogues of monoclonal antibodies. The research has included enough patients – more than six hundred people. All investigation phases of a bioanalogue were carried out in direct comparison with the original medicine Remicade®.
“According to preliminary tests, the domestic bioanalogue will reduce treatment cost by more than 50 percent on comparison with the cost of original medicine. The efficiency of this medicine is very high. Indications to its application a little. First of all, it is used for treatment of heavy rheumatoid arthritis which is steady against therapy by anti-inflammatory medicines of the chemical nature (30% of patients the disease shows a refractory to standard therapy). It is also effective at widespread heavy vulgar psoriasis and its steady forms - as at inefficiency of standard methods of treatment, and just for patients at whom treatment takes place hard there is a damage of joints or the big surface of a body is struck. Medicine is widely used also at psoriatic arthritis, an rheumatoid spondylitis, inflammatory diseases of intestines (a Krone disease and ulcer colitis), including children”, – Tatyana Pokrovskay said.
According to the scientist, infliximab doesn't enter the list of vital medicines approved by the Government of the Russian Federation, however patients have a preferential providing with it. These are ( first of all) the people having disability according to diagnoses.
The bioanalogue of an infliximab will go on sale this year. His emergence to the foreign markets – in Belarus, India, the CIS, Southeast Asia is planned.
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