biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Productsbiopreparat-11Research ArticleОБЗОРЫREVIEWSФармакокинетические свойства препаратов белковой природыPharmacokinetic properties of the preparations of protein originСолдатовА. А.SoldatovA. A.Soldatov@expmed.ruАвдееваЖ. И.AvdeevaZh. I.noemail@neicon.ruАлпатоваН. А.AlpatovaN. A.noemail@neicon.ruМедуницынН. В.MedunitsynN. V.noemail@neicon.ruЛысиковаС. Л.LysikovaS. L.noemail@neicon.ruМеркуловВ. А.MerkulovV. A.noemail@neicon.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Center on Expertise of Medical Application Products» of the Ministry of Health of the Russian FederationRussian Federation201520022018022435Copyright © Солдатов А.А., Авдеева Ж.И., Алпатова Н.А., Медуницын Н.В., Лысикова С.Л., Меркулов В.А., 20182018Солдатов А.А., Авдеева Ж.И., Алпатова Н.А., Медуницын Н.В., Лысикова С.Л., Меркулов В.А.Soldatov A.A., Avdeeva Z.I., Alpatova N.A., Medunitsyn N.V., Lysikova S.L., Merkulov V.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/11

Биологические препараты существенно отличаются от низкомолекулярных химических препаратов по молекулярной массе, многомерной структуре действующего вещества, наличием посттрансляционных модификаций, составу примесей и вспомогательных веществ, производственному процессу получения препарата и др. Данные особенности биологических препаратов оказывают влияние и на их фармакокинетические свойства. Изучение фармакокинетических свойств необходимо не только для обоснования эффективности биологического препарата, но и является ключевым исследованием для демонстрации подобия/сходства разрабатываемого биоподобного и референтного (оригинального) препаратов. Биологические препараты с высокой молекулярной массой при подкожном и внутримышечном введении из места инъекции вначале мигрируют в сосуды лимфатической системы, а затем попадают в кровь. На фармакокинетические свойства препаратов, имеющих в своем составе Fc фрагмент иммуноглобулина, оказывает влияние их способность взаимодействовать с Fcy и FcRn рецепторами. Практически все биологические препараты обладают иммуно-генностью, появление антител к препарату вызывает изменение не только фармакодинамических, но фармакокинетических свойств биологических препаратов. Оценка фармакокинетических свойств представляет собой сложный и трудоемкий процесс, например, изучение распределения препарата может потребовать в некоторых случаях использование радиоактивной метки.

Biological preparations differ substantially from low molecular weight chemicals in molecular weight, multidimensional structure of an active substance, presence of post-translational modifications, composition of impurities and excipients, drug manufacturing process, etc. These specific features of biological preparations also influence their pharmacokinetic properties. The assessment of pharmacokinetic properties is essential not only for the confirmation of the efficacy of a biological preparation, but it is also key aspect of demonstrating the similarity/analogy of a biosimilar preparation under development and the reference (original) preparation. High molecular weight biological preparations when administered subcutaneously and intramusculary initially migrate from the injection site into lymphatic vessels and then to blood. Pharmacokinetic properties of drugs with Fc region of immunoglobulin, are affected by their ability to interact with Fcy and FcRn receptors. Almost all biological preparations possess immunogenicity, the appearance of antibodies to a drug causes changes not only in pharmacodynamic but also in pharmacokinetic properties of biological products. The assessment of pharmacokinetic properties is a complicated and time-consuming process, for example, the study of drug distribution may in some cases require the use of a radioactive label.

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The authors declare that there are no conflicts of interest present.