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Biological Products. Prevention, Diagnosis, Treatment

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

Abstract

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.

About the Authors

Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Director General. Doctor of Medical Sciences


N. V. Medunitsyn
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Department Director. Doctor of Medical Sciences, professor, academician of RAS


Zh. I. Avdeeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations. Doctor of Medical Sciences, professor


A. A. Soldatov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations. Doctor of Medical Sciences


A. A. Movsesyants
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Test Center of Quality Expertise of medical immunobiological preparations. Doctor of Medical Sciences, professor


V. A. Merkulov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Deputy Director General for the expertise of drugs. Doctor of Medical Sciences, professor


V. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Director of Center for examination and control of medical immunobiological preparations. Doctor of Medical Sciences, professor


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Review

For citations:


Olefir Yu.V., Medunitsyn N.V., Avdeeva Zh.I., Soldatov A.A., Movsesyants A.A., Merkulov V.A., Bondarev V.P. Modern biological/biotechnological medicinal products. Topical issues and prospects for development. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(2):67-77. (In Russ.)

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