<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-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">10.17749/2070-4909.2020.13.1.64-70</article-id><article-id custom-type="elpub" pub-id-type="custom">farmaec-343</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 article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Обзорная публикация</subject></subj-group></article-categories><title-group><article-title>Economic challenges of oncological diseases’ pharmacotherapy</article-title><trans-title-group xml:lang="ru"><trans-title>Экономические проблемы фармакотерапии онкологических заболеваний</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4165-1726</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ушкалова</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Ushkalova</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Ушкалова Елена Андреевна – д.м.н., профессор, профессор кафедры общей и клинической фармакологии </p><p> </p><p> Researcher ID: A-4765-2017. РИНЦ SPIN-код: 7722-5802</p><p> </p></bio><bio xml:lang="en"><p>Elena A. Ushkalova – MD, Dr Sci Med, Professor, Department of General and Clinical Pharmacology</p><p> Researcher ID: A-4765-2017. Scopus Author ID: 56633092200. RISIN SPIN-code: 7722-5802</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/0000-0002-6348-6867</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Зырянов</surname><given-names>С. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Zyryanov</surname><given-names>S. K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Зырянов Сергей Кенсаринович – д.м.н., профессор, заведующий кафедрой общей и клинической фармакологии ; заместитель главного врача ГКБ 24 ДЗМ</p><p>Researcher ID:  D-8826-2012. РИНЦ SPIN-код: 2725-9981</p><p>ул. Миклухо-Маклая, д. 10/3, Москва 117198; ул. Писцовая, д. 10, Москва 27015</p></bio><bio xml:lang="en"><p>Sergey K. Zyryanov – MD, Dr Sci Med, Professor &amp; Head, Department of General and Clinical Pharmacology; Deputy Chief Medical Officer, Clinical Hospital No. 24</p><p>Researcher ID: D-8826-2012. RISIN SPIN-code: 2725-9981</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/0000-0003-3089-1804</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гопиенко</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Gopienko</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гопиенко Ирина Александровна – аспирант кафедры общей и клинической фармакологии</p><p> РИНЦ SPIN-код: 8192-4441</p><p>ул. Миклухо-Маклая, д. 10/3, Москва 117198</p></bio><bio xml:lang="en"><p>Irina A. Gopienko – Postgraduate student, Department of General and Clinical Pharmacology</p><p>RISIN SPIN-code: 8192-4441</p></bio><email xlink:type="simple">erin332@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Федеральное государственное автономное образовательное учреждение  высшего образования «Российский университет дружбы народов»<country>Россия</country></aff><aff xml:lang="en">Peoples’ Friendship University of Russia<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">Федеральное государственное автономное образовательное учреждение  высшего образования «Российский университет дружбы народов»; Государственное бюджетное учреждение города Москвы  «Городская клиническая больница № 24 Департамента здравоохранения города Москвы»<country>Россия</country></aff><aff xml:lang="en">Peoples’ Friendship University of Russia;  City Clinical Hospital No. 24 of the Moscow Department of Health<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2020</year></pub-date><pub-date pub-type="epub"><day>24</day><month>04</month><year>2020</year></pub-date><volume>13</volume><issue>1</issue><fpage>64</fpage><lpage>70</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Ushkalova E.A., Zyryanov S.K., Gopienko I.A., 2020</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="ru">Ушкалова Е.А., Зырянов С.К., Гопиенко И.А.</copyright-holder><copyright-holder xml:lang="en">Ushkalova E.A., Zyryanov S.K., Gopienko I.A.</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/343">https://www.pharmacoeconomics.ru/jour/article/view/343</self-uri><abstract><p>Oncological diseases rank high in the structure of population morbidity and mortality. They entail considerable direct and indirect economic costs. In the past decades, the cost of oncotherapy has increased significantly, which is largely conditioned by high prices of antitumor drugs, which on average increased by ten times in the past ten years. At the same time, many innovative medications have only minor advantages over cheaper old medications because they are registered based on the data on the achievement of the surrogate endpoint – extension of progression-free survival. The high cost of oncotherapy is associated with financial toxicity that affects negatively the patients’ quality of life, their adherence to treatment and consequently survival. To reduce the cost of oncotherapy, it is necessary to conduct pharma-economic analysis, the results of which can serve as the basis to negotiate price-cutting with the manufacturers, as well as to use high-quality generics and biosimilars as effective and safe as their originals, and to monitor effectiveness and safety of all antitumor drugs within the pharmacovigilance framework.</p></abstract><trans-abstract xml:lang="ru"><p>Онкологические заболевания занимают существенное место в структуре заболеваемости и смертности населения и сопряжены с высокими прямыми и непрямыми экономическими затратами. Стоимость лечения онкопатологий существенно выросла в последние десятилетия, что в значительной степени обусловлено высокими ценами противоопухолевых препаратов, которые за последние 10 лет увеличились в среднем в 10 раз. При этом многие инновационные препараты имеют лишь минимальные преимущества перед более дешевыми старыми препаратами, так как регистрируются на основании данных о достижении суррогатной конечной точки – удлинения периода без прогрессирования заболевания. Высокая стоимость терапии ассоциируется с финансовой токсичностью, негативно влияющей на качество жизни пациента, приверженностью лечению и выживаемостью. Для снижения стоимости лечения онкозаболеваний необходимо проведение фармакоэкономического анализа, результаты которого могут служить основанием для переговоров с производителями по поводу снижения цен, применение качественных генериков и биоаналогов, обладающих сходной эффективностью и безопасностью с оригинальными препаратами, а также мониторинг эффективности и безопасности всех противоопухолевых средств в рамках фармаконадзора.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>Онкология</kwd><kwd>стоимость лечения</kwd><kwd>финансовая токсичность</kwd><kwd>генерики</kwd><kwd>биоаналоги</kwd></kwd-group><kwd-group xml:lang="en"><kwd>Oncology</kwd><kwd>cost of treatment</kwd><kwd>financial toxicity</kwd><kwd>generics</kwd><kwd>biosimilars</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">GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: A systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015; 385: 117– 171. DOI: https://doi.org/10.1016/S0140-6736(14)61682-2.</mixed-citation><mixed-citation xml:lang="en">GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: A systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015; 385: 117– 171. DOI: https://doi.org/10.1016/S0140-6736(14)61682-2.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Злокачественные новообразования в России в 2018 году (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой М. 2019; 250 с. [Malignant neoplasms in Russia in 2018 (morbidity and mortality). Ed. A.D. Kaprin, V.V. Starinsky, G.V. Petrova. Moscow. 2019; 250 p. (in Russ)].</mixed-citation><mixed-citation xml:lang="en">Злокачественные новообразования в России в 2018 году (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой М. 2019; 250 с. [Malignant neoplasms in Russia in 2018 (morbidity and mortality). Ed. A.D. Kaprin, V.V. Starinsky, G.V. Petrova. Moscow. 2019; 250 p. (in Russ)].</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Torre L.A., Siegel R.L., Ward E.M., Jemal A. Global cancer incidence and mortality rates and trends – an update. Cancer Epidemiol Biomarkers Prev. 2016; 25: 16–27. DOI: https://doi.org/10.1158/10559965.EPI-15-0578.</mixed-citation><mixed-citation xml:lang="en">Torre L.A., Siegel R.L., Ward E.M., Jemal A. Global cancer incidence and mortality rates and trends – an update. Cancer Epidemiol Biomarkers Prev. 2016; 25: 16–27. DOI: https://doi.org/10.1158/10559965.EPI-15-0578.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Cancer – World Health Organization [Electronic resource] URL: https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed: 20.01.2020.</mixed-citation><mixed-citation xml:lang="en">Cancer – World Health Organization [Electronic resource] URL: https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed: 20.01.2020.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Farmer P., et al. Expansion of cancer care and control in countries of low and middle income: a call to action. Lancet. 2010; 376: 1186–93. DOI: https://doi.org/10.1016/S0140-6736(10)61152-X.</mixed-citation><mixed-citation xml:lang="en">Farmer P., et al. Expansion of cancer care and control in countries of low and middle income: a call to action. Lancet. 2010; 376: 1186–93. DOI: https://doi.org/10.1016/S0140-6736(10)61152-X.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Torre L.A., et al. Global cancer statistics, 2012. CA Cancer J Clin. 2015; 65 (2): 87-108. DOI: https://doi.org/10.3322/caac.21262.</mixed-citation><mixed-citation xml:lang="en">Torre L.A., et al. Global cancer statistics, 2012. CA Cancer J Clin. 2015; 65 (2): 87-108. DOI: https://doi.org/10.3322/caac.21262.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Bray F., et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018; 68 (6): 394-424. DOI: https://doi. org/10.3322/caac.21492.</mixed-citation><mixed-citation xml:lang="en">Bray F., et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018; 68 (6): 394-424. DOI: https://doi. org/10.3322/caac.21492.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Soerjomataram I., et al. Global burden of cancer in 2008: A systematic analysis of disability-adjusted life-years in 12 world regions. Lancet. 2012; 380: 1840–1850. DOI: https://doi.org/10.1016/S01406736(12)60919-2.</mixed-citation><mixed-citation xml:lang="en">Soerjomataram I., et al. Global burden of cancer in 2008: A systematic analysis of disability-adjusted life-years in 12 world regions. Lancet. 2012; 380: 1840–1850. DOI: https://doi.org/10.1016/S01406736(12)60919-2.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Prager G.W., et al. Global cancer control: responding to the growing burden, rising costs and inequalities in access. ESMO Open. 2018; 3 (2): e000285. DOI: https://doi.org/10.1136/esmoopen-2017-000285.</mixed-citation><mixed-citation xml:lang="en">Prager G.W., et al. Global cancer control: responding to the growing burden, rising costs and inequalities in access. ESMO Open. 2018; 3 (2): e000285. DOI: https://doi.org/10.1136/esmoopen-2017-000285.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Transforming our world: the 2030 Agenda for Sustainable Development [Electronic resource] URL: https://sustainabledevelopment. un.org/post2015/transformingourworld. Accessed: 20.01.2020.</mixed-citation><mixed-citation xml:lang="en">Transforming our world: the 2030 Agenda for Sustainable Development [Electronic resource] URL: https://sustainabledevelopment. un.org/post2015/transformingourworld. Accessed: 20.01.2020.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Greenberg D., et al. When is Cancer Care Cost-Effective? A Systematic Overview of Cost–Utility Analyses in Oncology. J Natl Cancer Inst. 2010; 102 (2): 82–8. DOI: https://doi.org/10.1093/jnci/djp472.</mixed-citation><mixed-citation xml:lang="en">Greenberg D., et al. When is Cancer Care Cost-Effective? A Systematic Overview of Cost–Utility Analyses in Oncology. J Natl Cancer Inst. 2010; 102 (2): 82–8. DOI: https://doi.org/10.1093/jnci/djp472.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Global Oncology Trends 2018 [Electronic resource] URL: https:// www.iqvia.com/insights/the-iqvia-institute/reports/global-oncologytrends-2018. Accessed: 20.01.2020.</mixed-citation><mixed-citation xml:lang="en">Global Oncology Trends 2018 [Electronic resource] URL: https:// www.iqvia.com/insights/the-iqvia-institute/reports/global-oncologytrends-2018. Accessed: 20.01.2020.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Understanding the Global Cancer Burden [Electronic resource] URL: https://old.cancer.org/acs/groups/content/@internationalaffairs/ documents/document/acspc-026203.pdf. Accessed: 20.01.2020.</mixed-citation><mixed-citation xml:lang="en">Understanding the Global Cancer Burden [Electronic resource] URL: https://old.cancer.org/acs/groups/content/@internationalaffairs/ documents/document/acspc-026203.pdf. Accessed: 20.01.2020.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Elkin E.B., Bach P.B. Cancer’s next frontier: addressing high and increasing costs. JAMA. 2010; 303 (11): 1086–1087. DOI: https://doi. org/10.1001/jama.2010.283.</mixed-citation><mixed-citation xml:lang="en">Elkin E.B., Bach P.B. Cancer’s next frontier: addressing high and increasing costs. JAMA. 2010; 303 (11): 1086–1087. DOI: https://doi. org/10.1001/jama.2010.283.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Barchuk A., et al. Productivity losses associated with premature mortality due to cancer in Russia: A population-wide study covering 2001-2030. Scand J Public Health. 2019 Jul; 47 (5): 482–491. DOI: https://doi.org/10.1177/1403494819845565.</mixed-citation><mixed-citation xml:lang="en">Barchuk A., et al. Productivity losses associated with premature mortality due to cancer in Russia: A population-wide study covering 2001-2030. Scand J Public Health. 2019 Jul; 47 (5): 482–491. DOI: https://doi.org/10.1177/1403494819845565.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Ignatyeva V.I., Derkach E.V., Avxentyeva M.V., Omelyanovsky V.V. The Cost of Melanoma and Kidney, Prostate, and Ovarian Cancers in Russia. Value Health Reg Issues. 2014; 4: 58–65. DOI: https://doi.org/10.1016/j.vhri.2014.07.002.</mixed-citation><mixed-citation xml:lang="en">Ignatyeva V.I., Derkach E.V., Avxentyeva M.V., Omelyanovsky V.V. The Cost of Melanoma and Kidney, Prostate, and Ovarian Cancers in Russia. Value Health Reg Issues. 2014; 4: 58–65. DOI: https://doi.org/10.1016/j.vhri.2014.07.002.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Runyan A., Banks J., Bruni D.S. Current and Future Oncology Management in the United States. J Manag Care Spec Pharm. 2019; 25 (2): 272–281. DOI: https://doi.org/10.18553/jmcp.2019.25.2.272.</mixed-citation><mixed-citation xml:lang="en">Runyan A., Banks J., Bruni D.S. Current and Future Oncology Management in the United States. J Manag Care Spec Pharm. 2019; 25 (2): 272–281. DOI: https://doi.org/10.18553/jmcp.2019.25.2.272.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Kelly R.J., Smith T.J. Delivering maximum clinical benefit at an affordable price: Engaging stakeholders in cancer care. Lancet Oncol. 2014, 15, e112–e118. DOI: https://doi.org/10.1016/S14702045(13)70578-3.</mixed-citation><mixed-citation xml:lang="en">Kelly R.J., Smith T.J. Delivering maximum clinical benefit at an affordable price: Engaging stakeholders in cancer care. Lancet Oncol. 2014, 15, e112–e118. DOI: https://doi.org/10.1016/S14702045(13)70578-3.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Prasad V., De Jesús K., Mailankody S. The high price of anticancer drugs: origins, implications, barriers, solutions. Nat Rev Clin Oncol. 2017; 14 (6): 381–390. DOI: https://doi.org/10.1038/nrclinonc.2017.31.</mixed-citation><mixed-citation xml:lang="en">Prasad V., De Jesús K., Mailankody S. The high price of anticancer drugs: origins, implications, barriers, solutions. Nat Rev Clin Oncol. 2017; 14 (6): 381–390. DOI: https://doi.org/10.1038/nrclinonc.2017.31.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">de Souza J.A., et al. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017; 123 (3): 476–484. DOI: https://doi.org/10.1002/cncr.30369.</mixed-citation><mixed-citation xml:lang="en">de Souza J.A., et al. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017; 123 (3): 476–484. DOI: https://doi.org/10.1002/cncr.30369.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Mariotto A.B., et al. Projections of the cost of cancer care in the United States: 2010–2020. J Natl Cancer Inst. 2011; 103: 117–128. J Natl Cancer Inst. 2011 Jan 19; 103 (2): 117–28. DOI: https://doi. org/10.1093/jnci/djq495.</mixed-citation><mixed-citation xml:lang="en">Mariotto A.B., et al. Projections of the cost of cancer care in the United States: 2010–2020. J Natl Cancer Inst. 2011; 103: 117–128. J Natl Cancer Inst. 2011 Jan 19; 103 (2): 117–28. DOI: https://doi. org/10.1093/jnci/djq495.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Prasad V., Mailankody S. How should we assess the value of innovative drugs in oncology? Lessons from cost-effectiveness analyses. Blood. 2015; 126: 1860–1. DOI: https://doi.org/10.1182/ blood-2015-07-657478.</mixed-citation><mixed-citation xml:lang="en">Prasad V., Mailankody S. How should we assess the value of innovative drugs in oncology? Lessons from cost-effectiveness analyses. Blood. 2015; 126: 1860–1. DOI: https://doi.org/10.1182/ blood-2015-07-657478.</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">Cheung W.Y., et al. The economic impact of the transition from branded to generic oncology drugs. Curr Oncol. 2019; 26 (2): 89–93. DOI: https://doi.org/10.3747/co.26.4395.</mixed-citation><mixed-citation xml:lang="en">Cheung W.Y., et al. The economic impact of the transition from branded to generic oncology drugs. Curr Oncol. 2019; 26 (2): 89–93. DOI: https://doi.org/10.3747/co.26.4395.</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Kantarjian H.M., Fojo T., Mathisen M., Zwelling L.A. Cancer drugs in the United States: Justum Pretium – the just price. J Clin Oncol. 2013; 31 (28): 3600–4. DOI: https://doi.org/10.1200/ JCO.2013.49.1845.</mixed-citation><mixed-citation xml:lang="en">Kantarjian H.M., Fojo T., Mathisen M., Zwelling L.A. Cancer drugs in the United States: Justum Pretium – the just price. J Clin Oncol. 2013; 31 (28): 3600–4. DOI: https://doi.org/10.1200/ JCO.2013.49.1845.</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">Fojo T., Mailankody S., Lo A. Unintended consequences of expensive cancer therapeutics – the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture. JAMA Otolaryngol Head Neck Surg. 2014; 140: 1225– 1236. DOI: https://doi.org/10.1001/jamaoto.2014.1570.</mixed-citation><mixed-citation xml:lang="en">Fojo T., Mailankody S., Lo A. Unintended consequences of expensive cancer therapeutics – the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture. JAMA Otolaryngol Head Neck Surg. 2014; 140: 1225– 1236. DOI: https://doi.org/10.1001/jamaoto.2014.1570.</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Kumar H., Fojo T., Mailankody S. An appraisal of clinically meaningful outcomes guidelines for oncology clinical trials. JAMA Oncol. 2016; 2 (9): 1238–40. DOI: https://doi.org/10.1001/ jamaoncol.2016.0931.</mixed-citation><mixed-citation xml:lang="en">Kumar H., Fojo T., Mailankody S. An appraisal of clinically meaningful outcomes guidelines for oncology clinical trials. JAMA Oncol. 2016; 2 (9): 1238–40. DOI: https://doi.org/10.1001/ jamaoncol.2016.0931.</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Del Paggio J.C., et al. Do contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit? Ann Oncol. 2017; 28 (1): 157–162. DOI: https://doi.org/10.1093/annonc/ mdw538.</mixed-citation><mixed-citation xml:lang="en">Del Paggio J.C., et al. Do contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit? Ann Oncol. 2017; 28 (1): 157–162. DOI: https://doi.org/10.1093/annonc/ mdw538.</mixed-citation></citation-alternatives></ref><ref id="cit28"><label>28</label><citation-alternatives><mixed-citation xml:lang="ru">Mitchell A.P., et al. Clinical trial participants with metastatic renal cell carcinoma differ from patients treated in real-world practice. J Oncol Pract. 2015; 11 (6): 491–7. DOI: https://doi.org/10.1200/ JOP.2015.004929.</mixed-citation><mixed-citation xml:lang="en">Mitchell A.P., et al. Clinical trial participants with metastatic renal cell carcinoma differ from patients treated in real-world practice. J Oncol Pract. 2015; 11 (6): 491–7. DOI: https://doi.org/10.1200/ JOP.2015.004929.</mixed-citation></citation-alternatives></ref><ref id="cit29"><label>29</label><citation-alternatives><mixed-citation xml:lang="ru">Sanoff H.K., et al. Sorafenib effectiveness in advanced hepatocellular carcinoma. Oncologist. 2016; 21 (9): 1113–20. DOI: https://doi.org/10.1634/theoncologist.2015-0478.</mixed-citation><mixed-citation xml:lang="en">Sanoff H.K., et al. Sorafenib effectiveness in advanced hepatocellular carcinoma. Oncologist. 2016; 21 (9): 1113–20. DOI: https://doi.org/10.1634/theoncologist.2015-0478.</mixed-citation></citation-alternatives></ref><ref id="cit30"><label>30</label><citation-alternatives><mixed-citation xml:lang="ru">Prasad V., Massey P.R., Fojo T. Oral anticancer drugs: how limited dosing options and dose reductions may affect outcomes in comparative trials and efficacy in patients. J Clin Oncol. 2014; 32 (15): 1620–9. DOI: https://doi.org/10.1200/JCO.2013.53.0204.</mixed-citation><mixed-citation xml:lang="en">Prasad V., Massey P.R., Fojo T. Oral anticancer drugs: how limited dosing options and dose reductions may affect outcomes in comparative trials and efficacy in patients. J Clin Oncol. 2014; 32 (15): 1620–9. DOI: https://doi.org/10.1200/JCO.2013.53.0204.</mixed-citation></citation-alternatives></ref><ref id="cit31"><label>31</label><citation-alternatives><mixed-citation xml:lang="ru">Mailankody S., Prasad V. Overall Survival in Cancer Drug Trials as a New Surrogate End Point for Overall Survival in the Real World. JAMA Oncol. JAMA Oncol. 2017; 3 (7): 889–890. DOI: https://doi. org/10.1001/jamaoncol.2016.5296.</mixed-citation><mixed-citation xml:lang="en">Mailankody S., Prasad V. Overall Survival in Cancer Drug Trials as a New Surrogate End Point for Overall Survival in the Real World. JAMA Oncol. JAMA Oncol. 2017; 3 (7): 889–890. DOI: https://doi. org/10.1001/jamaoncol.2016.5296.</mixed-citation></citation-alternatives></ref><ref id="cit32"><label>32</label><citation-alternatives><mixed-citation xml:lang="ru">Aggarwal A., et al. Do patient access schemes for high-cost cancer drugs deliver value to society?-lessons from the NHS Cancer Drugs Fund. Ann Oncol. 2017 Aug 1; 28 (8): 1738–1750. DOI: https:// doi.org/10.1093/annonc/mdx110.</mixed-citation><mixed-citation xml:lang="en">Aggarwal A., et al. Do patient access schemes for high-cost cancer drugs deliver value to society?-lessons from the NHS Cancer Drugs Fund. Ann Oncol. 2017 Aug 1; 28 (8): 1738–1750. DOI: https:// doi.org/10.1093/annonc/mdx110.</mixed-citation></citation-alternatives></ref><ref id="cit33"><label>33</label><citation-alternatives><mixed-citation xml:lang="ru">Trotta F., et al. Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy. BMJ Open. 2019; 9 (12): e033728. DOI: https://doi.org/10.1136/bmjopen-2019-033728.</mixed-citation><mixed-citation xml:lang="en">Trotta F., et al. Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy. BMJ Open. 2019; 9 (12): e033728. DOI: https://doi.org/10.1136/bmjopen-2019-033728.</mixed-citation></citation-alternatives></ref><ref id="cit34"><label>34</label><citation-alternatives><mixed-citation xml:lang="ru">Jiang D.M., et al. Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations. Cancer Med. 2019; 8 (4): 1584–1593. DOI: https://doi.org/10.1002/cam4.2058.</mixed-citation><mixed-citation xml:lang="en">Jiang D.M., et al. Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations. Cancer Med. 2019; 8 (4): 1584–1593. DOI: https://doi.org/10.1002/cam4.2058.</mixed-citation></citation-alternatives></ref><ref id="cit35"><label>35</label><citation-alternatives><mixed-citation xml:lang="ru">Schrag D. The price tag on progress – chemotherapy for colorectal cancer. N Engl J Med. 2004; 351: 317–319. DOI: https://doi. org/10.1056/NEJMp048143.</mixed-citation><mixed-citation xml:lang="en">Schrag D. The price tag on progress – chemotherapy for colorectal cancer. N Engl J Med. 2004; 351: 317–319. DOI: https://doi. org/10.1056/NEJMp048143.</mixed-citation></citation-alternatives></ref><ref id="cit36"><label>36</label><citation-alternatives><mixed-citation xml:lang="ru">Goldstein D.A. The ethical and practical challenges of valuebased cancer care at the patient’s bedside. JAMA Oncol. 2016; 2 (7): 860–1. DOI: https://doi.org/10.1001/jamaoncol.2016.0535.</mixed-citation><mixed-citation xml:lang="en">Goldstein D.A. The ethical and practical challenges of valuebased cancer care at the patient’s bedside. JAMA Oncol. 2016; 2 (7): 860–1. DOI: https://doi.org/10.1001/jamaoncol.2016.0535.</mixed-citation></citation-alternatives></ref><ref id="cit37"><label>37</label><citation-alternatives><mixed-citation xml:lang="ru">Savage P., Mahmoud S., Patel Y., Kantarjian H. Cancer drugs: an international comparison of postlicensing price inflation. J Oncol Pract. 2017; 13: e538–e542. DOI: https://doi.org/10.1200/JOP.2016.014431.</mixed-citation><mixed-citation xml:lang="en">Savage P., Mahmoud S., Patel Y., Kantarjian H. Cancer drugs: an international comparison of postlicensing price inflation. J Oncol Pract. 2017; 13: e538–e542. DOI: https://doi.org/10.1200/JOP.2016.014431.</mixed-citation></citation-alternatives></ref><ref id="cit38"><label>38</label><citation-alternatives><mixed-citation xml:lang="ru">Bower H., Björkholm M., Dickman P.W., et al. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the general population. J Clin Oncol. 2016; 34 (24): 2851–7. DOI: https://doi.org/10.1200/JCO.2015.66.2866.</mixed-citation><mixed-citation xml:lang="en">Bower H., Björkholm M., Dickman P.W., et al. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the general population. J Clin Oncol. 2016; 34 (24): 2851–7. DOI: https://doi.org/10.1200/JCO.2015.66.2866.</mixed-citation></citation-alternatives></ref><ref id="cit39"><label>39</label><citation-alternatives><mixed-citation xml:lang="ru">Bach P.B. Limits on Medicare’s ability to control rising spending on cancer drugs. N Engl J Med. 2009; 360 (6): 626–33. DOI: https:// doi.org/10.1056/NEJMhpr0807774.</mixed-citation><mixed-citation xml:lang="en">Bach P.B. Limits on Medicare’s ability to control rising spending on cancer drugs. N Engl J Med. 2009; 360 (6): 626–33. DOI: https:// doi.org/10.1056/NEJMhpr0807774.</mixed-citation></citation-alternatives></ref><ref id="cit40"><label>40</label><citation-alternatives><mixed-citation xml:lang="ru">Nardi E.A., et al. Value, Access, and Cost of Cancer Care Delivery at Academic Cancer Centers. J Natl Compr Canc Netw. 2016; 14 (7): 837–47. DOI: https://doi.org/10.6004/jnccn.2016.0088.</mixed-citation><mixed-citation xml:lang="en">Nardi E.A., et al. Value, Access, and Cost of Cancer Care Delivery at Academic Cancer Centers. J Natl Compr Canc Netw. 2016; 14 (7): 837–47. DOI: https://doi.org/10.6004/jnccn.2016.0088.</mixed-citation></citation-alternatives></ref><ref id="cit41"><label>41</label><citation-alternatives><mixed-citation xml:lang="ru">Knaul F., Frenk J., Shulman L. Closing the Cancer Divide: A Blueprint to Expand Access in Low and Middle Income Countries. In Social Science Research Network; Harvard Global Equity Initiative: Boston, MA, USA, 2011.</mixed-citation><mixed-citation xml:lang="en">Knaul F., Frenk J., Shulman L. Closing the Cancer Divide: A Blueprint to Expand Access in Low and Middle Income Countries. In Social Science Research Network; Harvard Global Equity Initiative: Boston, MA, USA, 2011.</mixed-citation></citation-alternatives></ref><ref id="cit42"><label>42</label><citation-alternatives><mixed-citation xml:lang="ru">Goss P.E., et al. Challenges to effective cancer control in China, India, and Russia. Lancet Oncol. 2014; 15 (5): 489–538. DOI: https:// doi.org/10.1016/S1470-2045(14)70029-4.</mixed-citation><mixed-citation xml:lang="en">Goss P.E., et al. Challenges to effective cancer control in China, India, and Russia. Lancet Oncol. 2014; 15 (5): 489–538. DOI: https:// doi.org/10.1016/S1470-2045(14)70029-4.</mixed-citation></citation-alternatives></ref><ref id="cit43"><label>43</label><citation-alternatives><mixed-citation xml:lang="ru">Zafar Y., et al. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. Oncologist. 2013; 18 (4): 381–90. DOI: https:// doi.org/10.1634/theoncologist.2012-0279.</mixed-citation><mixed-citation xml:lang="en">Zafar Y., et al. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. Oncologist. 2013; 18 (4): 381–90. DOI: https:// doi.org/10.1634/theoncologist.2012-0279.</mixed-citation></citation-alternatives></ref><ref id="cit44"><label>44</label><citation-alternatives><mixed-citation xml:lang="ru">Mahon F.X., et al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010; 11 (11): 1029-35. DOI: https://doi.org/10.1016/S1470-2045(10)70233-3.</mixed-citation><mixed-citation xml:lang="en">Mahon F.X., et al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010; 11 (11): 1029-35. DOI: https://doi.org/10.1016/S1470-2045(10)70233-3.</mixed-citation></citation-alternatives></ref><ref id="cit45"><label>45</label><citation-alternatives><mixed-citation xml:lang="ru">Carrera P.M., Kantarjian H.M., Blinder V.S. The Financial Burden and Distress of Patients with Cancer: Understanding and Stepping-Up Action on the Financial Toxicity of Cancer Treatment. CA Cancer J Clin. 2018; 68 (2): 153-165. DOI: https://doi.org/10.3322/caac.21443.</mixed-citation><mixed-citation xml:lang="en">Carrera P.M., Kantarjian H.M., Blinder V.S. The Financial Burden and Distress of Patients with Cancer: Understanding and Stepping-Up Action on the Financial Toxicity of Cancer Treatment. CA Cancer J Clin. 2018; 68 (2): 153-165. DOI: https://doi.org/10.3322/caac.21443.</mixed-citation></citation-alternatives></ref><ref id="cit46"><label>46</label><citation-alternatives><mixed-citation xml:lang="ru">Spencer J.C., et al. Oncology navigators’ perceptions of cancerrelated financial burden and financial assistance resources. Support Care Cancer. 2018; 26 (4): 1315-1321. DOI: https://doi.org/10.1007/ s00520-017-3958-3.</mixed-citation><mixed-citation xml:lang="en">Spencer J.C., et al. Oncology navigators’ perceptions of cancerrelated financial burden and financial assistance resources. Support Care Cancer. 2018; 26 (4): 1315-1321. DOI: https://doi.org/10.1007/ s00520-017-3958-3.</mixed-citation></citation-alternatives></ref><ref id="cit47"><label>47</label><citation-alternatives><mixed-citation xml:lang="ru">Zafar S.Y., et al. Population-based assessment of cancer survivors’ financial burden and quality of life: a prospective cohort study. J Oncol Pract. 2015; 11: 145–150. DOI: https://doi.org/10.1200/ JOP.2014.001542.</mixed-citation><mixed-citation xml:lang="en">Zafar S.Y., et al. Population-based assessment of cancer survivors’ financial burden and quality of life: a prospective cohort study. J Oncol Pract. 2015; 11: 145–150. DOI: https://doi.org/10.1200/ JOP.2014.001542.</mixed-citation></citation-alternatives></ref><ref id="cit48"><label>48</label><citation-alternatives><mixed-citation xml:lang="ru">Lathan C.S., et al. Association of financial strain with symptom burden and quality of life for patients with lung or colorectal cancer. J Clin Oncol. 2016; 34 (15): 1732–40. DOI: https://doi.org/10.1200/ JCO.2015.63.2232.</mixed-citation><mixed-citation xml:lang="en">Lathan C.S., et al. Association of financial strain with symptom burden and quality of life for patients with lung or colorectal cancer. J Clin Oncol. 2016; 34 (15): 1732–40. DOI: https://doi.org/10.1200/ JCO.2015.63.2232.</mixed-citation></citation-alternatives></ref><ref id="cit49"><label>49</label><citation-alternatives><mixed-citation xml:lang="ru">Kale H.P., Carroll N.V. Self-reported financial burden of cancer care and its effect on physical and mental health-related quality of life among US cancer survivors. Cancer. 2016; 122 (8): 283–9. DOI: https://doi.org/10.1002/cncr.29808.</mixed-citation><mixed-citation xml:lang="en">Kale H.P., Carroll N.V. Self-reported financial burden of cancer care and its effect on physical and mental health-related quality of life among US cancer survivors. Cancer. 2016; 122 (8): 283–9. DOI: https://doi.org/10.1002/cncr.29808.</mixed-citation></citation-alternatives></ref><ref id="cit50"><label>50</label><citation-alternatives><mixed-citation xml:lang="ru">Ramsey S.D., et al. Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol. 2016; 34 (9): 980– 6. DOI: https://doi.org/10.1200/JCO.2015.64.6620.</mixed-citation><mixed-citation xml:lang="en">Ramsey S.D., et al. Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol. 2016; 34 (9): 980– 6. DOI: https://doi.org/10.1200/JCO.2015.64.6620.</mixed-citation></citation-alternatives></ref><ref id="cit51"><label>51</label><citation-alternatives><mixed-citation xml:lang="ru">Bhoo-Pathy N., et al. Financial Toxicity After Cancer in a Setting With Universal Health Coverage: A Call for Urgent Action. J Oncol Pract. 2019; 15 (6): e537–e546. DOI: https://doi.org/10.1200/ JOP.18.00619.</mixed-citation><mixed-citation xml:lang="en">Bhoo-Pathy N., et al. Financial Toxicity After Cancer in a Setting With Universal Health Coverage: A Call for Urgent Action. J Oncol Pract. 2019; 15 (6): e537–e546. DOI: https://doi.org/10.1200/ JOP.18.00619.</mixed-citation></citation-alternatives></ref><ref id="cit52"><label>52</label><citation-alternatives><mixed-citation xml:lang="ru">Renner L., Nkansah F.A., Dodoo A.N. The role of generic medicines and biosimilars in oncology in low-income countries. Ann Oncol. 2013; 24 Suppl 5: v29–32. DOI: https://doi.org/10.1093/annonc/ mdt326.</mixed-citation><mixed-citation xml:lang="en">Renner L., Nkansah F.A., Dodoo A.N. The role of generic medicines and biosimilars in oncology in low-income countries. Ann Oncol. 2013; 24 Suppl 5: v29–32. DOI: https://doi.org/10.1093/annonc/ mdt326.</mixed-citation></citation-alternatives></ref><ref id="cit53"><label>53</label><citation-alternatives><mixed-citation xml:lang="ru">Witte J., et al. Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications. Ann Oncol. 2019; 30 (7): 1061–1070. DOI: https://doi. org/10.1093/annonc/mdz140.</mixed-citation><mixed-citation xml:lang="en">Witte J., et al. Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications. Ann Oncol. 2019; 30 (7): 1061–1070. DOI: https://doi. org/10.1093/annonc/mdz140.</mixed-citation></citation-alternatives></ref><ref id="cit54"><label>54</label><citation-alternatives><mixed-citation xml:lang="ru">Cherny N.I., et al. Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score. J Clin Oncol. 2019; 37 (4): 336–349. DOI: https://doi. org/10.1200/JCO.18.00729.</mixed-citation><mixed-citation xml:lang="en">Cherny N.I., et al. Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score. J Clin Oncol. 2019; 37 (4): 336–349. DOI: https://doi. org/10.1200/JCO.18.00729.</mixed-citation></citation-alternatives></ref><ref id="cit55"><label>55</label><citation-alternatives><mixed-citation xml:lang="ru">Bentley T.G.K., et al. Measuring the Value of New Drugs: Validity and Reliability of 4 Value Assessment Frameworks in the Oncology Setting. J Manag Care Spec Pharm. 2017; 23 (6-a Suppl): 34–48. DOI: https://doi.org/10.18553/jmcp.2017.23.6-a.s34.</mixed-citation><mixed-citation xml:lang="en">Bentley T.G.K., et al. Measuring the Value of New Drugs: Validity and Reliability of 4 Value Assessment Frameworks in the Oncology Setting. J Manag Care Spec Pharm. 2017; 23 (6-a Suppl): 34–48. DOI: https://doi.org/10.18553/jmcp.2017.23.6-a.s34.</mixed-citation></citation-alternatives></ref><ref id="cit56"><label>56</label><citation-alternatives><mixed-citation xml:lang="ru">Shah R.R., Stonier P.D. Repurposing old drugs in oncology: Opportunities with clinical and regulatory challenges ahead. Pharm Ther. 2019; 44 (1): 6–22. DOI: https://doi.org/10.1111/jcpt.12759.</mixed-citation><mixed-citation xml:lang="en">Shah R.R., Stonier P.D. Repurposing old drugs in oncology: Opportunities with clinical and regulatory challenges ahead. Pharm Ther. 2019; 44 (1): 6–22. DOI: https://doi.org/10.1111/jcpt.12759.</mixed-citation></citation-alternatives></ref><ref id="cit57"><label>57</label><citation-alternatives><mixed-citation xml:lang="ru">Conti R.M., Padula W.V., Larson R.A. Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU. Ann Hematol. 2015; 94 Suppl 2: S249–57. DOI: https://doi.org/10.1007/s00277-015-2319-x.</mixed-citation><mixed-citation xml:lang="en">Conti R.M., Padula W.V., Larson R.A. Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU. Ann Hematol. 2015; 94 Suppl 2: S249–57. DOI: https://doi.org/10.1007/s00277-015-2319-x.</mixed-citation></citation-alternatives></ref><ref id="cit58"><label>58</label><citation-alternatives><mixed-citation xml:lang="ru">Godman B., et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019; 8 (2): 49–70. DOI: https://doi.org/10.5639/gabij.2019.0802.007.</mixed-citation><mixed-citation xml:lang="en">Godman B., et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019; 8 (2): 49–70. DOI: https://doi.org/10.5639/gabij.2019.0802.007.</mixed-citation></citation-alternatives></ref><ref id="cit59"><label>59</label><citation-alternatives><mixed-citation xml:lang="ru">Choy E., Jacobs I.A. Biosimilar safety considerations in clinical practice. Semin Oncol. 2014; 41 Suppl 1: S3–14. DOI: https://doi. org/10.1053/j.seminoncol.2013.12.001.</mixed-citation><mixed-citation xml:lang="en">Choy E., Jacobs I.A. Biosimilar safety considerations in clinical practice. Semin Oncol. 2014; 41 Suppl 1: S3–14. DOI: https://doi. org/10.1053/j.seminoncol.2013.12.001.</mixed-citation></citation-alternatives></ref><ref id="cit60"><label>60</label><citation-alternatives><mixed-citation xml:lang="ru">Kabir E.R., Moreino S.S., Sharif Siam M.K. The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy. Biomolecules. 2019; 9 (9). pii: E410. DOI: https://doi.org/10.3390/biom9090410.</mixed-citation><mixed-citation xml:lang="en">Kabir E.R., Moreino S.S., Sharif Siam M.K. The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy. Biomolecules. 2019; 9 (9). pii: E410. DOI: https://doi.org/10.3390/biom9090410.</mixed-citation></citation-alternatives></ref><ref id="cit61"><label>61</label><citation-alternatives><mixed-citation xml:lang="ru">Yang Y.T., Nagai S., Chen B.K., et al. Generic oncology drugs: are they all safe? Lancet Oncol. 2016; 17 (11): e493–e501. DOI: https:// doi.org/10.1016/S1470-2045(16)30384-9.</mixed-citation><mixed-citation xml:lang="en">Yang Y.T., Nagai S., Chen B.K., et al. Generic oncology drugs: are they all safe? Lancet Oncol. 2016; 17 (11): e493–e501. DOI: https:// doi.org/10.1016/S1470-2045(16)30384-9.</mixed-citation></citation-alternatives></ref><ref id="cit62"><label>62</label><citation-alternatives><mixed-citation xml:lang="ru">American Society of Clinical Oncology. American Society of Clinical Oncology Position Statement on Addressing the Affordability of Cancer Drugs. J Oncol Pract. 2018; 14 (3): 187–192. DOI: https:// doi.org/10.1200/JOP.2017.027359.</mixed-citation><mixed-citation xml:lang="en">American Society of Clinical Oncology. American Society of Clinical Oncology Position Statement on Addressing the Affordability of Cancer Drugs. J Oncol Pract. 2018; 14 (3): 187–192. DOI: https:// doi.org/10.1200/JOP.2017.027359.</mixed-citation></citation-alternatives></ref><ref id="cit63"><label>63</label><citation-alternatives><mixed-citation xml:lang="ru">European Medicines Agency. Products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015.</mixed-citation><mixed-citation xml:lang="en">European Medicines Agency. Products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
