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<article article-type="review-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">farmaec</journal-id><journal-title-group><journal-title xml:lang="en">FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology</journal-title><trans-title-group xml:lang="ru"><trans-title>ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2070-4909</issn><issn pub-type="epub">2070-4933</issn><publisher><publisher-name>IRBIS LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.17749/2070-4909/farmakoekonomika.2026.363</article-id><article-id custom-type="elpub" pub-id-type="custom">farmaec-1374</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEW ARTICLES</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРНЫЕ ПУБЛИКАЦИИ</subject></subj-group></article-categories><title-group><article-title>Incretin-based therapy under pricing pressure: clinico-economic perspectives and role of biosimilar glucagon-like peptide-1 receptor agonists</article-title><trans-title-group xml:lang="ru"><trans-title>Инкретиновая терапия в эпоху ценового давления: клинико-экономические перспективы и роль биоаналогов агонистов рецептора глюкагоноподобного пептида-1</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-5484-9574</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кособуцкая</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kosobutskaya</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кособуцкая Светлана Александровна, к.м.н. </p><p>ул. Трубецкая, д. 8, стр. 2, Москва 119048</p></bio><bio xml:lang="en"><p>Svetlana A. Kosobutskaya, PhD </p><p>8 bldg 2 Trubetskaya Str., Moscow 119048</p></bio><email xlink:type="simple">kosobutskaya233@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0008-8195-5912</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Аушева</surname><given-names>Д. Х.</given-names></name><name name-style="western" xml:lang="en"><surname>Ausheva</surname><given-names>D. Kh.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Аушева Дали Хажбикаровна </p><p>ул. Трубецкая, д. 8, стр. 2, Москва 119048</p></bio><bio xml:lang="en"><p>Dali K. Ausheva </p><p>8 bldg 2 Trubetskaya Str., Moscow 119048</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0001-2803-8700</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Амирова</surname><given-names>М. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Amirova</surname><given-names>M. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Амирова Мадина Абдурразаковна </p><p>ул. Трубецкая, д. 8, стр. 2, Москва 119048</p></bio><bio xml:lang="en"><p>Madina A. Amirova </p><p>8 bldg 2 Trubetskaya Str., Moscow 119048</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0004-7096-569X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белая</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Belaya</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Белая Мария Владимировна </p><p>ул. Островитянова, д. 1, стр. 6, Москва 117513</p></bio><bio xml:lang="en"><p>Mariya V. Belaya </p><p>1, bldg 6 Ostrovityanov Stе., Moscow 117513</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0006-4721-8527</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Старцева</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Startseva</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Старцева Софья Александровна </p><p>ул. Островитянова, д. 1, стр. 6, Москва 117513</p></bio><bio xml:lang="en"><p>Sofiya A. Startseva </p><p>1, bldg 6 Ostrovityanov Stе., Moscow 117513</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0006-9005-8725</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Самохина</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Samokhina</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Самохина Алина Александровна </p><p>ул. Островитянова, д. 1, стр. 6, Москва 117513</p></bio><bio xml:lang="en"><p>Alina A. Samokhina </p><p>1, bldg 6 Ostrovityanov Stе., Moscow 117513</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0000-4482-2063</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Васильева</surname><given-names>Я. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Vasileva</surname><given-names>Ya. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Васильева Яна Александровна</p><p>ул. Островитянова, д. 1, стр. 6, Москва 117513</p></bio><bio xml:lang="en"><p>Yana A. Vasileva </p><p>1, bldg 6 Ostrovityanov Stе., Moscow 117513</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0007-1661-7397</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кочеткова</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kochetkova</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кочеткова Софья Александровна </p><p>ул. Островитянова, д. 1, стр. 6, Москва 117513</p></bio><bio xml:lang="en"><p>Sofiya A. Kochetkova </p><p>1, bldg 6 Ostrovityanov Stе., Moscow 117513</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0004-7671-0137</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Цомаев</surname><given-names>Б. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Tsomaev</surname><given-names>B. P.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Цомаев Батраз Павлович </p><p>ул. Пушкинская, д. 40, Владикавказ 362019</p></bio><bio xml:lang="en"><p>Batraz P. Tsomaev </p><p>40 Pushkinskaya Stк., Vladikavkaz 362019</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0001-5871-0262</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дзгоев</surname><given-names>Г. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Dzgoev</surname><given-names>G. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Дзгоев Георгий Мирославович </p><p>ул. Пушкинская, д. 40, Владикавказ 362019</p></bio><bio xml:lang="en"><p>Georgiy M. Dzgoev </p><p>40 Pushkinskaya Stк., Vladikavkaz 362019</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0005-1362-9945</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кокаева</surname><given-names>Н. Т.</given-names></name><name name-style="western" xml:lang="en"><surname>Kokaeva</surname><given-names>N. T.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кокаева Нелли Тимуровна </p><p>ул. Пушкинская, д. 40, Владикавказ 362019</p></bio><bio xml:lang="en"><p>Nelli T. Kokaeva </p><p>40 Pushkinskaya Stк., Vladikavkaz 362019</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0004-1218-0675</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сидакова</surname><given-names>М. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Sidakova</surname><given-names>M. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сидакова Милана Ибрагимовна </p><p>ул. Пушкинская, д. 40, Владикавказ 362019</p></bio><bio xml:lang="en"><p>Milana I. Sidakova </p><p>40 Pushkinskaya Stк., Vladikavkaz 362019</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0004-2910-0483</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Касаева</surname><given-names>А. Т.</given-names></name><name name-style="western" xml:lang="en"><surname>Kasaeva</surname><given-names>A. T.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Касаева Алина Тимуровна </p><p>ул. Пушкинская, д. 40, Владикавказ 362019</p></bio><bio xml:lang="en"><p>Alina T. Kasaeva </p><p>40 Pushkinskaya Stк., Vladikavkaz 362019</p></bio><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)<country>Россия</country></aff><aff xml:lang="en">Sechenov University<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">Федеральное государственное автономное образовательное учреждение высшего образования «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">Pirogov Russian National Research Medical University<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru">Федеральное государственное бюджетное образовательное учреждение высшего образования «Северо-Осетинская государственная медицинская академия» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">North Ossetian State Medical Academy<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>06</day><month>05</month><year>2026</year></pub-date><volume>0</volume><issue>0</issue><issue-title>Online First</issue-title><elocation-id>1374</elocation-id><permissions><copyright-statement>Copyright &amp;#x00A9; Kosobutskaya S.A., Ausheva D.K., Amirova M.A., Belaya M.V., Startseva S.A., Samokhina A.A., Vasileva Y.A., Kochetkova S.A., Tsomaev B.P., Dzgoev G.M., Kokaeva N.T., Sidakova M.I., Kasaeva A.T., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Кособуцкая С.А., Аушева Д.Х., Амирова М.А., Белая М.В., Старцева С.А., Самохина А.А., Васильева Я.А., Кочеткова С.А., Цомаев Б.П., Дзгоев Г.М., Кокаева Н.Т., Сидакова М.И., Касаева А.Т.</copyright-holder><copyright-holder xml:lang="en">Kosobutskaya S.A., Ausheva D.K., Amirova M.A., Belaya M.V., Startseva S.A., Samokhina A.A., Vasileva Y.A., Kochetkova S.A., Tsomaev B.P., Dzgoev G.M., Kokaeva N.T., Sidakova M.I., Kasaeva A.T.</copyright-holder><license license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmacoeconomics.ru/jour/article/view/1374">https://www.pharmacoeconomics.ru/jour/article/view/1374</self-uri><abstract><p>The prevalence of obesity and type 2 diabetes mellitus continues to rise, imposing a substantial medical, social, and economic burden on healthcare systems worldwide. Glucagon-like peptide-1 receptor agonists have demonstrated robust efficacy in glycemic control, weight management, and cardiovascular risk mitigation, which has led to their widespread integration into clinical practice. However, the high cost of originator products, recurrent supply shortages, and inequitable access to therapy remain significant barriers, particularly within constrained healthcare budgets. This review analyzes current data on the clinical comparability of biosimilars of glucagon-like peptide-1 receptor agonists, regulatory requirements for their approval, and international experience with their clinical uptake. Particular attention is given to economic considerations, including the impact of price competition on treatment costs, out-of-pocket expenditures, and potential budgetary implications. Real-world evidence suggests that the financial burden may adversely affect treatment initiation, adherence, and timely achievement of therapeutic targets. Noteworthy is that the introduction of biosimilars does not automatically translate into substantial price reductions; this requires supportive regulatory and reimbursement policies, transparent pricing mechanisms, effective pharmacovigilance, and educational initiatives for both clinicians and patients. In the Russian context, the integration of biosimilars may enhance improved access to incretin-based therapy, provided that standards of quality, safety, and evidence-based evaluation are maintained. Achieving a balance between clinical effectiveness and economic sustainability is essential for ensuring long-term accessibility of glucagon-like peptide-1 receptor agonist therapy amid growing demand.</p></abstract><trans-abstract xml:lang="ru"><p>Распространенность ожирения и сахарного диабета 2-го типа продолжает расти, формируя устойчивую медико-социальную и экономическую нагрузку на системы здравоохранения. Агонисты рецептора глюкагоноподобного пептида-1 продемонстрировали клиническую эффективность в отношении гликемического контроля, снижения массы тела и уменьшения сердечно-сосудистого риска, что обусловило их широкое внедрение в терапевтическую практику. Однако высокая стоимость оригинальных препаратов, эпизоды дефицита и неравномерный доступ к лечению ограничивают их применение, особенно в условиях бюджетных ограничений. В обзоре проанализированы современные данные о клинической сопоставимости биоаналогов агонистов рецептора глюкагоноподобного пептида-1, регуляторных требованиях к их регистрации и международном опыте внедрения. Особое внимание уделено экономическим аспектам: влиянию ценовой конкуренции на стоимость терапии, структуре расходов пациентов и потенциальному эффекту для систем здравоохранения. Оценены данные реальной клинической практики, свидетельствующие о том, что финансовая нагрузка может снижать приверженность к лечению и отсрочивать достижение терапевтических целей. Показано, что появление биоаналогов не гарантирует автоматического снижения цен и требует комплексных мер регулирования, включая прозрачные механизмы ценообразования, фармаконадзор и образовательные инициативы. В российском контексте внедрение биоаналогов может способствовать расширению доступа к терапии при условии сохранения стандартов качества и доказательной базы. Рациональное сочетание клинической эффективности и экономической целесообразности рассматривается как ключевой фактор устойчивости инкретиновой терапии в условиях растущего спроса.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>агонисты рецептора глюкагоноподобного пептида-1</kwd><kwd>инкретиновая терапия</kwd><kwd>биоаналоги</kwd><kwd>сахарный диабет 2-го типа</kwd><kwd>ожирение</kwd><kwd>фармакоэкономика</kwd><kwd>доступность терапии</kwd><kwd>анализ влияния на бюджет</kwd><kwd>стоимость лечения</kwd><kwd>иммуногенность</kwd></kwd-group><kwd-group xml:lang="en"><kwd>glucagon-like peptide-1 receptor agonists</kwd><kwd>incretin-based therapy</kwd><kwd>biosimilars</kwd><kwd>type 2 diabetes mellitus</kwd><kwd>obesity</kwd><kwd>pharmacoeconomics</kwd><kwd>treatment accessibility</kwd><kwd>budget impact analysis</kwd><kwd>treatment costs</kwd><kwd>immunogenicity</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Celletti F., Farrar J., De Regil L. 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