biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2019-19-1-17-27biopreparat-185Research ArticleОБЗОРЫREVIEWSРегистрация неоригинальных биотерапевтических (биоподобных) препаратов в СШАAuthorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USAhttps://orcid.org/0000-0001-6624-2692СолдатовА. А.SoldatovA. A.

д-р мед. наук, главный эксперт управления экспертизы аллергенов, цитокинов и других иммуномодуляторов

Doctor of Medical Sciences, Chief Expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products

Soldatov@expmed.ruhttps://orcid.org/0000-0002-9377-1378АвдееваЖ. И.AvdeevaZh. I.

д-р мед. наук, профессор, главный эксперт управления экспертизы аллергенов, цитокинов и других иммуномодуляторов

Doctor of Medical Sciences, Professor, Chief Expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products

https://orcid.org/0000-0001-6472-6386БондаревВ. П.BondarevV. P.

д-р мед. наук, профессор, директор

Doctor of Medical Sciences, Professor, Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products

https://orcid.org/0000-0003-0269-8337МосягинВ. Д.MosyaginV. D.

д-р мед. наук, профессор, начальник управления экспертизы аллергенов, цитокинов и других иммуномодуляторов

Doctor of Medical Sciences, Professor, Head of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products

«Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской федерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation2019210220191911727Copyright © Солдатов А.А., Авдеева Ж.И., Бондарев В.П., Мосягин В.Д., 20192019Солдатов А.А., Авдеева Ж.И., Бондарев В.П., Мосягин В.Д.Soldatov A.A., Avdeeva Z.I., Bondarev V.P., Mosyagin V.D.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/185

Подготовка научных принципов разработки неоригинальных биотерапевтических (биоподобных, биоаналоговых) препаратов была начата в Европе в начале 2000-х гг., в 2009 г. они были утверждены на международной конференции ВОЗ в Сеуле с участием стран с развитой фарминдустрией. В США закон о биоподобных препаратах принят в 2012 г., за основу были взяты документы и рекомендации, подготовленные ЕМА и одобренные ВОЗ. В 2015 г. FDA опубликовало очередную редакцию основных документов, касающихся биоподобных препаратов. В основе нормативных требований США по разработке и регистрации биоподобных препаратов лежит пошаговая сравнительная оценка биоподобного и оригинального препаратов по атрибутам качества, эффективности и безопасности в соответствии с рекомендациями ВОЗ/ЕМА. При этом по таким вопросам, как дизайн сравнительных исследований качества (физико-химических и биологических свойств), присвоение Международного непатентованного наименования и взаимозаменяемость биоподобных препаратов, нормативные требования США отличаются от национальных рекомендаций других стран, в том числе ЕМА (ВОЗ).

European competent authorities began to elaborate scientific principles of development of non-innovator biotherapeutic (biosimilar) products in the early noughties, and in 2009 these principles were approved at the WHO International Conference in Seoul gathering participants from countries with a well-developed pharmaceutical industry. The USA adopted the law on biosimilar products in 2012, it was based on the documents and recommendations prepared by the EMA and approved by the WHO. In 2015, the FDA published the new revised versions of the guidelines dealing with biosimilar products. The US regulatory requirements for development and authorisation of biosimilar products are based on a step-by-step comparative assessment of biosimilar and innovator products in terms of their quality, efficacy, and safety in accordance with the WHO/EMA recommendations. At the same time the US regulatory requirements differ from those of other national authorities, including EMA (WHO), when it comes to the design of comparative quality studies (studies of products’ physicochemical and biological properties), the assignment of International Non-Proprietary Names and the interchangeability of biosimilar products.

биоподобные препаратыбиоаналоговые препаратыбиосимилярыэкстраполяциявзаимозаменяемостьрегистрация биоподобных препаратовbiosimilar productsbiosimilarsextrapolationinterchangeabilityauthorisation of biosimilar productsРабота выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00154-19-00 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590049-0)The study reported in this publication was carried out as part of a publicly funded research project No. 056-00154-19-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. AAAA-A18-118021590049-0)ReferencesDudzinski DM, Kesselheim AS. Scientific and legal viability of follow-on protein drugs. N Engl J Med. 2008;358(8):843– 9. https://doi.org/10.1056/NEJMhle0706973Dudzinski DM, Kesselheim AS. Scientific and legal viability of follow-on protein drugs. N Engl J Med. 2008;358(8):843- 9. https://doi.org/10.1056/NEJMhle0706973Carver KH, Elikan J, Lietzan E. An unofficial legislative history of the Biologics Price Competition and Innovation Act of 2009. Food Drug Law J. 2010;65(4):671–818.Carver KH, Elikan J, Lietzan E. An unofficial legislative history of the Biologics Price Competition and Innovation Act of 2009. Food Drug Law J. 2010;65(4):671-818.Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol. 2015;55(S3):S123–32. https://doi.org/10.1002/jcph.339Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol. 2015;55(S3):S123-32. https://doi.org/10.1002/jcph.339Fonseca JE, Gonçalves J, Araújo F, Cordeiro I, Teixeira F, Canhão H, et al. The Portuguese Society of Rheumatology position paper on the use of biosimilars. Acta Reumatol. Port. 2014;39(1):60–71.Fonseca JE, Gonçalves J, Araújo F, Cordeiro I, Teixeira F, Canhão H, et al. The Portuguese Society of Rheumatology position paper on the use of biosimilars. Acta Reumatol. Port. 2014;39(1):60-71.Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev. 2014;13(7):751–5. https://doi.org/10.1016/j.autrev.2014.02.004Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev. 2014;13(7):751-5. https://doi.org/10.1016/j.autrev.2014.02.004Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T. Joint position statement by «Sociedad Española de Patología Digestiva» (Spanish Society of Gastroenterology) and «Sociedad Española de Farmacología» (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig. 2013;105(1):37–43.Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T. Joint position statement by «Sociedad Española de Patología Digestiva» (Spanish Society of Gastroenterology) and «Sociedad Española de Farmacología» (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig. 2013;105(1):37-43.Grampp G, Bonafede M, Felix T, Li E, Malecki M, Sprafka JM. Active and passive surveillance of enoxaparin generics: A case study relevant to biosimilars. Expert Opin Drug Saf. 2015;14(3):349–60. https://doi.org/10.1517/14740338.2015.1001364Grampp G, Bonafede M, Felix T, Li E, Malecki M, Sprafka JM. Active and passive surveillance of enoxaparin generics: A case study relevant to biosimilars. Expert Opin Drug Saf. 2015;14(3):349-60. https://doi.org/10.1517/14740338.2015.1001364Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3(4):889–99. https://doi.org/10.1002/cam4.258Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3(4):889-99. https://doi.org/10.1002/cam4.258

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