rpmjResearch'n Practical Medicine JournalResearch and Practical Medicine Journal2410-1893"QUASAR", LLC10.17709/2409-2231-2016-3-2-6rpmj-137Research ArticleОбзоры, лекцииReviews, lecturesВОЗМОЖНО ЛИ ИСПОЛЬЗОВАНИЕ БИОАНАЛОГА БЕВАЦИЗУМАБА ПРИ ВСЕХ ПОКАЗАНИЯХ, ЗАРЕГИСТРИРОВАННЫХ ДЛЯ ОРИГИНАЛЬНОГО ПРЕПАРАТА?IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG?ОрловС. В.OrlovS. V.

Sergey V. Orlov – MD, PhD, prof., leading researcher of oncology department

ШимановскийН. Л.ShimanovskiiN. L.

Шимановский Николай Львович – доктор медицинских наук, профессор, член-корр. РАН, заведующий кафедрой молекулярной фармакологии и радиобиологии им. академика П. В. Сергеева

Nikolay L. Shimanovskii – MD, PhD, prof., corresponding member of RAS, head of molecular pharmacology and radiobiology department named after academician P. V. Sergeev

ФогтС. Н.FogtS. N.

Фогт Сергей Николаевич – кандидат медицинских наук, медицинский советник II категории, направление «Онкология»

Для корреспонденции: ЗАО «БИОКАД» Адрес: 198515, Россия, Санкт-Петербург, п. Стрельна, ул. Связи, 34, лит. А E-mail: fogt@biocad.ru

Sergey N. Fogt – MD, PhD, medical advisor of second category, direction «Oncology»,

For correspondence: JSC «BIOCAD» Address: 34-A, ul. Svyazi, Strelna,Saint Petersburg, 198515, Russia E-mail: fogt@biocad.ru

fogt@biocad.ruПервый Санкт-Петербургский государственный медицинский университет им. академика И.П. ПавловаРоссияFirst Saint Petersburg State Medical University named after Academician I.P. Pavlov, Saint PetersburgRussian FederationРоссийский национальный исследовательский медицинский университет им. Н.И. Пирогова, МоскваРоссияNational Research Medical University named after N.I. Pirogov, MoscowRussian FederationБИОКАД, ЗАО, Санкт-ПетербургРоссияBIOCAD JSCSaint PetersburgRussian Federation201601072016324552Copyright © Орлов С.В., Шимановский Н.Л., Фогт С.Н., 20162016Орлов С.В., Шимановский Н.Л., Фогт С.Н.Orlov S.V., Shimanovskii N.L., Fogt S.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpmj.ru/rpmj/article/view/137

Возможность экстраполяции показаний для биоаналогов – один из вопросов, широко обсуждаемых в современной литературе. В настоящее время Европейское Агентство по Изучению Лекарственных Средств (EMA – European Medicines Agency) и Управление по контролю качества пищевых продуктов и лекарственных препаратов (FDA – Food and Drug Administration) определили специальные условия, при которых для биоаналога возможна экстраполяция показаний. В2015 г. был зарегистрирован первый биоаналог бевацизумаба (производства BIOCAD). В статье приводятся краткие сведения о регистрационном клиническом исследовании препарата, проведенном на пациентах с немелкоклеточным раком легкого. Приводится подробное научное обоснование для экстраполяции данных по эффективности, безопасности и иммуногенности, полученных в исследовании, на другие показания, зарегистрированные для оригинального препарата бевацизумаба.

The possibility of extrapolation of indications for biosimilars is one of the issues widely discussed in modern literature. Currently, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have identified specific conditions under which for biosimilars extrapolation of indications is possible. In2015, athe first bioanalogue bevacizumab, (produced by JSC "BIOCAD"), has been registered. The article provides summary of the pivotal clinical study of Bevacizumab bioanalogue conducted in patients with non-small cell lung cancer. The article includes detailed scientific justification for the extrapolation of data on the efficacy, safety and immunogenicity obtained in the pivotal study to other indications, registered for the original bevacizumab drug.

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