A cure for autoimmune diseases
The Ministry of Health has registered the first domestic biosimilar of infliximab
The Ministry of Health has registered the first Russian biosimilar of infliximab BCD-055, developed by the biotech company BIOCAD, which will help significantly reduce the cost of therapy for rheumatoid arthritis and psoriasis for Russian patients.
In Russia, only 10% of patients with rheumatoid arthritis who need genetically engineered biological drugs receive such therapy. However, the real need is much higher. According to the official statistics of the Ministry of Health, 295 thousand patients with rheumatoid arthritis and 291 thousand patients with psoriasis have been registered in the Russian Federation. However, the prevalence of these diseases is much higher, 1-2% in the population, totaling more than 2.5 million people. The cost of an annual course of therapy with infliximab ranges from 500 to 850 thousand rubles. About 3.5 billion rubles are allocated annually for the treatment of rheumatoid arthritis.
Infliximab is the very first genetically engineered biological drug based on monoclonal antibodies, which was registered in the world for the treatment of autoimmune diseases in 2004. The drug has several indications for use. First of all, it is used for the treatment of severe rheumatoid arthritis, which is resistant to therapy with anti-inflammatory drugs of a chemical nature (in 30% of patients, the disease has a refractory course to standard therapy).
The drug is also indicated for common severe vulgar psoriasis, and its stable forms - both with the ineffectiveness of standard treatment methods, and simply for patients whose treatment is difficult, there is a joint lesion, or a large body surface is affected. Infliximab is widely used for psoriatic arthritis, ankylosing spondylitis, inflammatory bowel diseases (Crohn's disease and ulcerative colitis), including in children.
Rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis are characterized by the presence of distinct immune-mediated developmental mechanisms that play an important role in the pathophysiology of each individual disease and are realized in severe chronic inflammation. The inflammatory response in patients underlying all of these diseases is expressed in the constant hyperproduction of various pro-inflammatory cytokines, primarily tumor necrosis factor alpha and interleukin-6.
Early initiation of infliximab therapy prevents disability of patients. Thus, from the point of view of social significance, increasing the availability of this drug for a wider range of Russian patients will contribute to reducing the number of disabled people among the able-bodied population of the country (rheumatoid arthritis has long ceased to be only a problem of the elderly, it often affects young people aged 30 to 55 years, whereas psoriasis can be contracted almost in any age).
The development of the domestic infliximab biosimilar has been carried out by BIOCAD since 2013. By March 2017, the main stage of clinical trials was completed, and a complete registration dossier was prepared.
Clinical trials of the Russian drug BCD-055 were conducted in full compliance with European recommendations for the study of monoclonal antibody biosimilars, included a one-year phase I study and two one-year phase III studies at once, and involved 625 patients. Investments in the BIOCAD project amounted to about 1 billion rubles, - such high costs are certainly related to the fact that all stages of the biosimilar research were carried out in direct comparison with the original drug.
"The drug BCD-055 is the fourth registered biosimilar of monoclonal antibodies of our company. There is no doubt that a great future awaits him, because at all stages of the study, the drug BCD-055 showed full equivalence to the original drug," emphasizes the vice president for development and research of the biotech company BIOCAD Roman Ivanov. – Many doctors regretted that clinical trials were coming to an end, as this meant the end of the use of our drug. It is probably difficult to find a more eloquent confirmation that the drug BCD-055 works perfectly."
The analysis of efficacy, safety and immunogenicity demonstrated the absence of significant differences between BCD-055 and the original drug. The safety analysis showed that both drugs have similar tolerability characteristics: no differences were shown in any of the evaluated safety parameters, no cases of unforeseen toxicity were detected.
The leading medical centers of Russia and Belarus were connected to the program of clinical trials of the drug: North-Western State Medical University named after I.I. Mechnikov, Belgorod State National Research University, Chelyabinsk Regional Clinical Hospital, Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky, Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko, 1st City Clinical Hospital (Minsk) and many others.
The biosimilar will go on sale this year. According to preliminary estimates, the domestic drug will reduce the cost of treatment by more than 50% compared to the cost of the original drug before the release of biosimilars. It is planned to expand into foreign markets – Belarus, India, the CIS, Southeast Asia.
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