Taube Aleksandra Albertovna
The successful development of the economy of a modern state is directly related to the entry into the market of new advanced therapy medicinal products. For Russia, the process of developing and implementing biomedical cell products will become the basis for the successful transformation of the pharmaceutical market into a knowledge-intensive market economy. Biomedical cell products can act as one of the main tools of such a promising and capital-intensive direction as regenerative medicine. The field of biomedical cell products therapy is developing rapidly, but there are still questions about the safe use of biomedical cell products therapy. The growing need for effective recommendations for the participants of the biomedical cell products market has determined the relevance of this study. Multivariate analysis of the prospects and barriers to the development of the biomedical cell products market to justify and develop recommendations for investors, pharmaceutical manufacturers and distributors for the production and sale of biomedical cell products in Russia. Materials and methods. The materials were regulatory legal documents of regulatory bodies: the USA, the EU, the Russian Federation, the EAEU, as well as analytical materials of open access. Results. A comparative analysis of the production features and the formation of the cost of autologous and allogeneic biomedical cell products revealed the ways of development of the biomedical cell products market. Further, the key directions of the prospective development of the biomedical cell products market were identified and characterized, risk factors, drivers and barriers were identified. Conclusion. In the direction of regulatory support: – create a general register for monitoring the results of research and the use of biomedical cell products. – to develop an information environment for comparing large sets of biomedical cell products life cycle data obtained from different sources; – to develop regulatory approaches to the circulation of biomedical cell products in the market. In the direction of technological support: – plan the implementation of automation of all stages of the production process; – to provide for the development of technology transfer methods; – to maintain the pharmaceutical quality system in an up-to-date functioning state; – implement a platform for training qualified personnel for this field. In the direction of marketing support: – to create logistics chain systems, with the help of integration technologies, capable of ensuring uninterrupted supply of biomedical cell products with minimal risks to the quality of the supply chain reliability; – supply planning should take into account the stability and storage conditions of the biomedical cell products; – scaling up production leads to a reduction in cost, and an increase in the use of biomedical cell products in routine medical practice leads to an increase in the present value; – conduct training of production employees, distributors and medical personnel. – develop a commercialization strategy for each biomedical cell products separately.
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.
The successful development of the economy of a modern state is directly related to the entry into the market of new advanced therapy medicinal products. For Russia, the process of developing and implementing biomedical cell products will become the basis for the successful transformation of the pharmaceutical market into a knowledge-intensive market economy. Biomedical cell products can act as one of the main tools of such a promising and capital-intensive direction as regenerative medicine. The field of biomedical cell products therapy is developing rapidly, but there are still questions about the safe use of biomedical cell products therapy. The growing need for effective recommendations for the participants of the biomedical cell products market has determined the relevance of this study. Multivariate analysis of the prospects and barriers to the development of the biomedical cell products market to justify and develop recommendations for investors, pharmaceutical manufacturers and distributors for the production and sale of biomedical cell products in Russia. Materials and methods. The materials were regulatory legal documents of regulatory bodies: the USA, the EU, the Russian Federation, the EAEU, as well as analytical materials of open access. Results. A comparative analysis of the production features and the formation of the cost of autologous and allogeneic biomedical cell products revealed the ways of development of the biomedical cell products market. Further, the key directions of the prospective development of the biomedical cell products market were identified and characterized, risk factors, drivers and barriers were identified. Conclusion. In the direction of regulatory support: – create a general register for monitoring the results of research and the use of biomedical cell products. – to develop an information environment for comparing large sets of biomedical cell products life cycle data obtained from different sources; – to develop regulatory approaches to the circulation of biomedical cell products in the market. In the direction of technological support: – plan the implementation of automation of all stages of the production process; – to provide for the development of technology transfer methods; – to maintain the pharmaceutical quality system in an up-to-date functioning state; – implement a platform for training qualified personnel for this field. In the direction of marketing support: – to create logistics chain systems, with the help of integration technologies, capable of ensuring uninterrupted supply of biomedical cell products with minimal risks to the quality of the supply chain reliability; – supply planning should take into account the stability and storage conditions of the biomedical cell products; – scaling up production leads to a reduction in cost, and an increase in the use of biomedical cell products in routine medical practice leads to an increase in the present value; – conduct training of production employees, distributors and medical personnel. – develop a commercialization strategy for each biomedical cell products separately.
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.
