Modern biological/biotechnological medicinal products. Topical issues and prospects for development

• Main Authors: Yu. V. Olefir, N. V. Medunitsyn, Zh. I. Avdeeva, A. A. Soldatov, A. A. Movsesyants, V. A. Merkulov, V. P. Bondarev
• Format: Article
• Language: Russian
• Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
• Series: Биопрепараты: Профилактика, диагностика, лечение
• Subjects: биологические, биотехнологические препараты; орфанные препараты; препараты клеточной и тканевой терапии; специфическая иммунотерапия аллергических заболеваний; биоаналогичные (биоподобные) препараты; biological and biotechnological preparations; orphan drugs; preparations of cell and tissue therapy; specific immunotherapy of allergic diseases; biosimilars
• Online Access: https://www.biopreparations.ru/jour/article/view/45
• ISSN: 2221-996X; 2619-1156

The review provides with the information, related to the development, research and registration of new biological preparations, including the issues of terminology and classification. It also highlights the issues of and prospects for genetically engineered drugs, specific aspects of comparative studies to prove the similarity of a biosimilar and the original (reference) medicine, clinical use and interchangeability of preparations, prospects for the development of biotechnological medicines, expert evaluation of the quality of biological/ biotechnological medicines, modern methods of immunotherapy of allergic diseases by recombinant medicines, as well as the issues of cell technology and tissue engineering. The review also describes the topics discussed at the 14th International Conference «High Medical Technologies of 21st Century» (October 24-31, 2015, Spain), related to fundamental and applied research, development and introduction of new technologies and modern medicines into clinical practice.