Ramenskaya G.V., Smirnov V.V., Taube A.A., Shubnikova E.E., Iurchenko A.. 276

Studying the potential of the russian market of medicines based on monoclonal antibodies

Monoclonal antibodies are monospecific in nature and are produced by B-lymphocytes that are cloning of the same cell with exclusive affinity and specificity for a single antigen epitope. Medicines based on monoclonal antibodies are the most common, high-tech, sold and promising segment of the domestic pharmaceutical market. The article considers the possibilities and possibilities of the market for new biosimilar drugs in the dosage form of lyophilisate. The purpose of the work is to study the potential opportunities for localizing the production in the Russian Federation of drugs based on monoclonal antibodies in the dosage form of lyophilisate. The search was carried out by international non-proprietary names (INN) and anatomical-therapeutic-chemical classification (ATC) codes. In the study, methods of marketing analysis and the method of statistical data processing were applied. A study of the market for medicinal products based on monoclonal antibodies in lyophilic form produced in the territory of the Russian Federation showed its significant growth over the period from 2016 to 2020. In monetary terms, production increased from 1.997 to 7589 billion rubles, which amounted to 20% and 45%, respectively. As a result of the analysis, it was found that as of March 2022, the patent protection period for the following INNs has expired: basiliximab, infliximab, omalizumab, trastuzumab. An analysis of the structure of the LP wound based on monoclonal antibodies was carried out. All drugs based on monoclonal antibodies are included in the list of vital and essential drugs, the pricing of which is regulated by the state. The absolute volume of state financing of drugs based on monoclonal antibodies increased from 9,928 to 16,801 million rubles from 2016 to 2020. The dynamics of sales of medicines based on monoclonal antibodies has been studied. There is an increase in sales in physical and monetary terms of localized drugs based on monoclonal antibodies in lyophilic form, however, the potential for localization remains significant. A portfolio of drugs based on monoclonal antibodies in the dosage form «lyophilisate» has been formed, promising for localization of production in the Russian Federation in terms of the criteria for the expiration of patent protection and the level of sales in the Russian Federation.
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