REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot171610.32687/1561-5936-2024-28-4-329-336Original ArticleThe review of the Russian biotech drugs marketKhalimovaAlina A.alina.khalimova@pharminnotech.comTrofimovaElena O.elena.trofimova@pharminnotech.comOrlovAlexander S.alexander.orlov@pharminnotech.comSt. Petersburg State Chemical and Pharmaceutical University, St. Petersburg, Russia15122024432933615102025Copyright © 2024,2024The biopharmaceutical industry is a major source of innovation and a driver of development of both the global pharmaceutical market and the different national markets, including the Russian one. The development of the Russian market of biotech drugs was facilitated by the expansion of state drug supply programs and the formation of the Russian pharmaceutical industry. The aim of the study was to assess the nomenclature, volumes and values, dynamics and structure of the Russian BD market in 2013–2023. BDs were identified as medicinal products obtained using recombinant DNA technology. Materials and methods. The study was based on the state registration, patent and scientific information, as well as sales data of DSM Group. Market segmentation was carried out considering the allocated groups of BDs, as well as ATC classification system. Results and discussion. In 2023 in Russia the sales value of BD related to 168 INNs amounted to RUB 288.4 billion in wholesale prices. In the sales structure, the main BD groups were mAbs and hormones. The leading therapeutic classes were antineoplastic agents and immunosuppressants, while orphan drugs accounted for 27.3% of the sales. Since 2013, the compound annual growth rates of BD sales in Russia have exceeded the global figures. BDs share in the Russian pharmaceutical market was significantly smaller than in the global market. Market share of biosimilars mostly represented by domestic products was high. The share of Russian-made drugs mainly provided by a limited list of companies increased to 30.8% by 2023 due to the development of biosimilars and original drugs. Conclusion. The BD segment has been remained as the most actively developing part of the Russian pharmaceutical market, where are concentrated the activities of the leading Russian companies aimed at the development of biosimilars and original drugs.biotech drugsrecombinant DNA technologybiosimilarsoriginal drugsmonoclonal antibodiesthe Russian pharmaceutical marketthe Russian pharmaceutical industryбиотехнологические лекарственные препаратытехнология рекомбинантной ДНКбиоаналогиоригинальные разработкимоноклональные антителароссийский фармацевтический рынокроссийская фармацевтическая отрасль1.Sanchez-Garcia L., Martín L., Mangues R. et al. Recombinant pharmaceuticals from microbial cells: a 2015 update. Microb. Cell Fact. 2016;15:33. DOI: 10.1186/s12934-016-0437-32.López-Siguero J. P., Palla Garcia M., Martínez Busto E. et al. Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice. Anales de pediatria. 2018;88(4):209–215. DOI: 10.1016/j.anpe-di.2017.03.0073.Gabibov A. G., Ponomarenko N. A., Vorobyev I. I. et al. Prospects for designing Russian gene engineering agents for medicine. Rastan is the first Russian recombinant human growth hormone. Problems of Endocrinology. 2007;53(2):19–24. DOI: 10.14341/probl200753219-244.Trofimova E. O., Denisova M. N. Results of the development of the public sector of the Russian pharmaceutical market in 2019—2021. Remedium. 2022;26(4):318–324. DOI: 10.32687/1561-5936-2022-26-4-318-3245.Khalimova A. A. Definition and classification of biotechnological drugs for the purposes of economic analysis. In: Challenges of globalization and the development of digital society in the new reality. Proceedings of the IX International Scientific and Practical Conference (Pyatigorsk, July 10, 2023). Makhachkala; 2023:22–32. DOI: 10.34755/IROK.2023.96.20.093 (In Russ.)6.Khalimova A. A., Orlov A. S., Taube A. A. Analysis of biopharmaceutical manufacturing localization in Russia considering the country of origin of active pharmaceutical ingredients. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2024;14(1):53–61. DOI: 10.30895/1991-2919-2024-14-1-53-61