Биосимиляры: новый этап развития фармакологии. Чем интересны инсулиновые биоаналоги?
Демидова Т.Ю., Титова В.В., Саверская Е.Н. Биосимиляры: новый этап развития фармакологии. Чем интересны инсулиновые биоаналоги? FOCUS Эндокринология. 2021; 3: 39–47. DOI: 10.47407/ef2021.2.3.0033
Demidova T.Yu., Titova V.V., Saverskaia E.N. Biosimilars: new era of pharmacology. What is interesting about insulin biosimilars. FOCUS Endocrinology. 2021; 3: 39–47. DOI: 10.47407/ef2021.2.3.0033
Доступность биологических препаратов для пациентов оказывает большое влияние на успех в лечении многих как острых, так и хронических заболеваний. Производство биосимиляров развивается по всему миру, способствуя снижению стоимости лечения и повышению доступности медицинской помощи. Более низкая цена на биосимиляры и эффективность, аналогичная эффективности исходных биопрепаратов, повышают рентабельность системы здравоохранения, а снижение затрат на биоаналоги может быть использовано для расширения до-ступа пациентов к терапии или перераспределения медицинских затрат на другие потребности.
Ключевые слова: биосимиляр, инсулин, сахарный диабет, биотерапия.
Ключевые слова: биосимиляр, инсулин, сахарный диабет, биотерапия.
1. Henry D, Taylor C. Pharmacoeconomics of Cancer Therapies: Considerations With the Introduction of Biosimilars. Semin Oncol 2014; 41: S13–S20. DOI: 10.1053/j.seminoncol.2014.03.009
2. Smolen JS, Landewé R, Bijlsma J et al. EULAR recommendations for the man-agement of rheumatoid arthritis with synthetic and biological disease-modify-ing antirheumatic drugs: 2016 update. Ann Rheumat Diseas 2017; 76 (6), 960–
77. DOI: 10.1136/annrheumdis-2016-210715
3. Heinemann L. Biosimilar Insulin and Costs. J Diabet Sci Technol 2015; 10 (2): 457–62. DOI: 10.1177/1932296815605337
4. European Medicines Agency. Guideline on similar biological medicinal prod-ucts (Rev. 1). Official Website of European Medicines Agency. 2014 (October 23). https://www.ema.europa.eu/en/documents/scientific-guideline/guide-line-similar-biological-medicinal-...
5. Дедов И.И., Шестакова М.В., Петеркова В.А. и др. Проект рекомендаций Российской ассоциации эндокринологов по применению биосимиляров инсулина. Сахарный диабет. 2021; 24 (1): 76–9.
[Dedov I.I., Shestakova M.V., Peterkova V.A. et al. Proekt rekomendatsii Rossi-iskoi assotsiatsii endokrinologov po primeneniiu biosimiliarov insulina. Sakharnyi diabet. 2021; 24 (1): 76–9 (in Russian)].
6. Malozowski S. Biosimilars. Arq Bras Endocrinol Metab 2011; 55 (8): 669–9. DOI: 10.1590/s0004-27302011000800025
7. Об утверждении «Правил проведения исследований биологических ле-карственных средств Евразийского экономического союза». Решение Совета ЕЭК от 3 ноября 2016 г. №89. URL: www.docs.cntd.ru (дата обра-щения: 05.09.2021).
[Ob utverzhdenii "Pravil provedeniia issledovanii biologicheskikh lekarstven-nykh sredstv Evraziiskogo ekonomicheskogo soiuza'. Reshenie Soveta EEK ot 3 noiabria 2016 g. №89. URL: www.docs.cntd.ru (data obrashcheniia: 05.09.2021) (in Russian)].
8. Сohen H, Beydoun D, Chien D et al. Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians. Adv Ther 2017; 33 (12): 2160–72. DOI: 10.1007/s12325-016-0431-5. Epub 2016 Oct 31. PMID: 27798772; PM-CID: PMC5126187
9. Шестакова М.В., Викулова О.К., Железнякова А.В. и др. Эпидемиология са-харного диабета в Российской Федерации: что изменилось за последнее десятилетие? Терапевтический архив. 2019; 91 (10): 4–13. DOI: 10.26442/00403660.2019.10.000364
[Shestakova M.V., Vikulova O.K., Zhelezniakova A.V. et al. Epidemiologiia sakharnogo diabeta v Rossiiskoi Federatsii: chto izmenilos' za poslednee desi-atiletie? Terapevticheskii arkhiv. 2019; 91 (10): 4–13. DOI: 10.26442/00403660.2019.10.000364 (in Russian)].
10. Шестакова М.В., Ефремова Н.В., Болотская Л.Л. и др. Сравнительный анализ эффективности гликемического контроля и частоты разви-тия микроангиопатий у пациентов с сахарным диабетом 1-го типа, получающих терапию генноинженерными инсулинами человека или аналогами инсулина человека: данные 10-летнего ретроспективного наблюдения. Сахарный диабет. 2016; 19 (5): 388–96. DOI: 10.14341/DM8050
[Shestakova M.V., Efremova N.V., Bolotskaia L.L. et al. Sravnitel'nyi analiz effek-tivnosti glikemicheskogo kontrolia i chastoty razvitiia mikroangiopatii u pat-sientov s sakharnym diabetom 1-go tipa, poluchaiushchikh terapiiu gen-noinzhenernymi insulinami cheloveka ili analogami insulina cheloveka: dan-nye 10-letnego retrospektivnogo nabliudeniia. Sakharnyi diabet. 2016; 19 (5): 388–96. DOI: 10.14341/DM8050 (in Russian)].
11. Демидова Т.Ю., Балутина О.В. Особенности высококонцентрированных инсулинов: основные характеристики и результаты исследований. Са-харный диабет. 2019; 22 (5): 481–90. DOI: 10.14341/DM10334
[Demidova T.Iu., Balutina O.V. Osobennosti vysokokontsentrirovannykh insuli-nov: osnovnye kharakteristiki i rezul'taty issledovanii. Sakharnyi diabet. 2019; 22 (5): 481–90. DOI: 10.14341/DM10334 (in Russian)].
12. Thalange N, Bereket A, Larsen J et al. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes 2011; 12 (7): 632–41. DOI: 10.1111/j.1399-5448.2010.00750.x
13. U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs – Hu-mulin R. Official website of the U.S. Food and Drug Administration. 1982 (Oc-tober 28). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018780
14. Ниязов Р.Р., Драницына М.А., Васильев А.Н., Гавришина Е.В. Биоаналоги: разработка и изучение с помощью современных биотехнологий. Сахар-ный диабет. 2020; 23 (6): 548–560. DOI: 10.14341/DM12576
[Niiazov R.R., Dranitsyna M.A., Vasil'ev A.N., Gavrishina E.V. Bioanalogi: razrabotka i izuchenie s pomoshch'iu sovremennykh biotekhnologii. Sakharnyi diabet. 2020; 23 (6): 548–560. DOI: 10.14341/DM12576 (in Russian)].
15. Reilly MS, Schneider PJ. Policy recommendations for a sustainable biosimilars market: lessons from Europe. GaBI Journal 2020; 9 (2): 76–83. DOI: 10.5639/gabij.2020.0902.013
16. Kyriakopoulos S, Kontoravdi C. Analysis of the landscape of biologically-de-rived pharmaceuticals in Europe: dominant production systems, molecule types on the rise and approval trends. Eur J Pharm Sci 2013; 48: 428–41. DOI: 10.1016/j.ejps. 2012.11.016
17. Климонтов В.В., Мякина Н.Е. Биосимиляры аналогов инсулина: что мы должны о них знать. Эффективная фармакотерапия. 2015; 7. eLIBRARY ID: 23239358
[Klimontov V.V., Miakina N.E. Biosimiliary analogov insulina: chto my dolzhny
o nikh znat'. Effektivnaia farmakoterapiia. 2015; 7. eLIBRARY ID: 23239358 (in Russian)].
18. Evans DB, Hsu J, Boerma T. Universal health coverage and universal access. Bull World Health Organ 2013; 91 (8): 546–6A. DOI: 10.2471/BLT.13.125450. PMID: 23940398; PMCID: PMC3738317
19. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther 2013; 93: 170–6.
20. Schiel JE, Mire-Sluis A, Davis D. Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials. ACS Symposium Series; American Chemical Society: Washington, DC. 2014. http://pubs.acs.org/DOI/Pdf/ 10.1021/bk-2014-1176.ch001
21. Global biosimilar insulin sales market report, 2021. URL: www.qyresearch.com
22. Официальный сайт ОО «Герофарм», Россия. URL: www.geropharm.ru/[Ofitsial'nyi sait OO "Gerofarm", Rossiia. URL: www.geropharm.ru/ (in Rus-sian)].
23. Федеральный закон «Об обращении лекарственных средств» №61-ФЗ от 12.04.2010 с дополнениями от 27.12.2019 «О внесении изменений в Федеральный закон “Об обращении лекарственных средств“ № 475-ФЗ». [Federal'nyi zakon "Ob obrashchenii lekarstvennykh sredstv' №61-FZ ot 12.04.2010 s dopolneniiami ot 27.12.2019 "O vnesenii izmenenii v Federal'nyi zakon “Ob obrashchenii lekarstvennykh sredstv“ № 475-FZ". (in Russian)].
24. Bui LA, Hurst S, Finch GL et al. Key considerations in the preclinical develop-ment of biosimilars. Drug Discov Today 2015; 20 (Suppl. 1): 3–15.
25. Camacho LH, Frost CP, Abella E et al. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med 2014; 3: 889–99.
26. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol 2008; 19: 411–9.
27. Ahmed I, Kaspar B, Sharma U. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 2012; 34: 400–19.
28. Mann M, Jensen ON. Proteomic analysis of post-translational modifications. Nat Biotechnol 2003; 21: 255–61.
29. Walsh G, Jefferis R. Post-translational modifications in the context of therapeu-tic proteins. Nat Biotechnol 2006; 24: 1241–52.
30. Li F, Vijayasankaran N, Shen AY et al. Cell culture processes for monoclonal an-tibody production. MAbs 2010; 2: 466–79.
31. Al-Sabbagh A, Olech E, McClellan JE, Kirchhoff CF. Development of biosimilars. Semin Arthritis Rheum 2016; 45: S11–8.
32. Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthri-tis Rheum 2015; 44: S2–8.
33. Liu HF, Ma J, Winter C et al. Recovery and purification process development for monoclonal antibody production. MAbs 2010; 2: 480–99.
34. Crutchlow MF, Palcza JS, Mostoller KM et al. Single-dose euglycaemic clamp studies demonstrating pharmacokinetic and pharmacodynamic similarity be-tween MK-1293 insulin glargine and originator insulin glargine (Lantus) in subjects with type 1 diabetes and healthy subjects. Diabetes Obes Metab 2018; 20 (2): 400–8. DOI: 10.1111/dom.13084
35. Kapitza C, Nowotny I, Lehmann A et al. Similar pharmacokinetics and pharma-codynamics of rapid-acting insulin lispro products SAR342434 and US- and EU-approved Humalog in subjects with type 1 diabetes. Diabetes Obes Metab 2017; 19 (5): 622–7. DOI: 10.1111/dom.12856
36. Майоров А.Ю., Драй Р.В., Каронова Т.Л. и др. Оценка биоподобия препа-ратов РинГлар® (ООО «Герофарм», Россия) и Лантус® («Санофи-Авен-тис Дойчланд ГмбХ», Германия) с использованием метода эугликеми-ческого гиперинсулинемического клэмпа у пациентов с сахарным диа-бетом 1-го типа: двойное слепое рандомизированное клиническое ис-следование. Сахарный диабет. 2020; 23 (4): 304–15. DOI: 10.14341/DM10095
[Maiorov A.Iu., Drai R.V., Karonova T.L. et al. Otsenka biopodobiia preparatov RinGlar® (OOO "Gerofarm', Rossiia) i Lantus® ("Sanofi-Aventis Doichland Gm-bKh', Germaniia) s ispol'zovaniem metoda euglikemicheskogo giperinsuline-micheskogo klempa u patsientov s sakharnym diabetom 1-go tipa: dvoinoe slepoe randomizirovannoe klinicheskoe issledovanie. Sakharnyi diabet. 2020; 23 (4): 304–15. DOI: 10.14341/DM10095 (in Russian)].
37. European Medicines Agency. Guideline on non-clinical and clinical develop-ment of similar biological medicinal products containing recombinant human insulin and insulin analogues. 2015 (February 26). EMEA/CHMP/BMWP/32775/2005_Rev. 1
38. Draft FDA guidance – Development of Therapeutic Protein Biosimilars: Com-parative Analytical Assessment and Other Quality-Related Considerations, May 2019.
39. О порядке определения взаимозаменяемости лекарственных препара-тов для медицинского применения. Постановление Правительства Российской Федерации от 05.09.2020 №1360. https://docs.cntd.ru/docu-ment/565687356 (дата обращения: 05.09.2021).
[O poriadke opredeleniia vzaimozameniaemosti lekarstvennykh preparatov dlia meditsinskogo primeneniia. Postanovlenie Pravitel'stva Rossiiskoi Feder-atsii ot 05.09.2020 №1360. https://docs.cntd.ru/document/565687356 (data obrashcheniia: 05.09.2021) (in Russian)].
40. Мосикян А.А., Бабенко А.Ю., Макаренко И.Е. Иммуногенность препара-тов инсулинов: краеугольный камень в оценке безопасности. РМЖ. 2019; 4: 32–7.
[Mosikian A.A., Babenko A.Iu., Makarenko I.E. Immunogennost' preparatov in-sulinov: kraeugol'nyi kamen' v otsenke bezopasnosti. RMZh. 2019; 4: 32–7 (in Russian)].
41. Strand V, Cronstein B. Biosimilars: How similar? Intern Med J 2014; 44 (3): 218–23. DOI: 10.1111/imj.12292
42. Mellstedt H. Anti-neoplastic biosimilars–the same rules as for cytotoxic gener-ics cannot be applied. Ann Oncol 2013; 24 (Suppl. 5): v23-8. http://www.ncbi.nlm.nih.gov/ pubmed/23975701
43. Paul S, Tedesco ED, Genin C, Roblin X. Review article: Biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther 2013; 38: 914–92.
44. Jeske W, Hoppensteadt D. Update on the safety and bioequivalence of biosimi-lars – focus on enoxaparin. Drug Healthc Patient Saf 2013; 5: 133–41.
45. Reunioes de reflexao da Revista Potuguesa de Farmacoterapia: Medicamentos Biossimilares. Rev Port Farmacoter 2013; 5.
46. Casadevall N, Edwards IR et al. Pharmacovigilance and biosimilars: Consider-ations, needs and challenges. Expert Opin Biol Ther 2013; 13 (7): 1039–47.
47. Нu X, Chen F. Exogenous insulin antibody syndrome (EIAS): a clinical syndrome associated with insulin antibodies induced by exogenous insulin in diabetic pa-tients. Endocr Connect 2018; 7 (1): R47-R55. DOI: 10.1530/EC-17-0309
48. Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products, 2014. http://www.fda.gov/Drugs/GuidanceComplianceRegulatory-Information/Guidances/default.htm
49. Кaronova TL, Mosikian AA, Mayorov AY et al. Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus®): a randomized open-label clinical trial. J Comp Eff Res 2020; 9 (4): 263–73. DOI: 10.2217/cer-2019-0136
50. Simoensa S, Vulto AG. A health economic guide to market access of biosimilars. Exp Opinion Biol Ther 2021; 21 (1): 9–17. DOI: 10.1080/14712598. 2021.1849132
51. Heredia E, Ribeiro A. Discount offered by first and subsequent biosimilars in the US, EU and LATAM: impact trends of originator starting price, market dynam-ics and regulations. Value Health 2018; 21 (Suppl. 1): S103–S104. DOI: 10.1016/j.jval.2018.04.700
52. Moorkens E, Vulto AG, Huys I et al. Policies for biosimilar uptake in Europe: An overview. PLOS ONE 2017; 12 (12): e0190147. DOI: 10.1371/journal. pone.0190147
53. Evaluate Pharma World Preview, 2019. Outlook to 2024. http://www.eval-uate.com/PharmaWorldPreview2019
54. Biosimilars in the United States 2020–2024 Competition, Savings, and Sus-tainability. IQVIA Institute Report. 2020 (Sep. 29). https://www.iqvia.com/en/insights/the-iqvia-institute/reports/biosimi-lars-in-the-united-states-2020...
55. Rognoni C, Bertolani A, Jommi C. Budget impact analysis of rituximab biosimilar in Italy from the hospital and payer perspectives. Glob Reg Health Technol Asse 2018; 20: 1–11.
56. Aladul MI, Fitzpatrick RW, Chapman SR. Impact of infliximab and etaner-cept biosimilars on biological disease-modifying antirheumatic drugs utili-sation and NHS budget in the UK. BioDrugs 2017; 31 (6): 533–544. PubMed PMID: 29127626.
57. Calleja-Hernández MA, Martínez-Sesmero JM, Santiago-Josefat B. Biosimi-lars of monoclonal antibodies in inflammatory diseases and cancer: current situation, challenges, and opportunities. Farm Hosp 2020; 44 (3): 100–8.
58. Sun D, Andayani TM, Altyar A et al. Potential cost savings from chemother-apy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European Union G5 countries: a simulation study. Clin Ther 2015; 37 (4): 842–57. DOI: 10.1016/ j.clinthera.2015.01.011
59. Abraham I, Han L, Sun D et al. Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries. Future Oncol 2014; 10 (9): 1599–609. DOI: 10.2217/fon.14.43
60. Franken MG, Kanters TA, Coenen JL et al. Potential cost savings owing to the route of administration of oncology drugs: a microcosting study of intra-venous and subcutaneous administration of trastuzumab and rituximab in the Netherlands. Anticancer Drugs 2018; 29 (8): 791–801. DOI: 10.1097/CAD.0000000000000648
61. Jackisch C, Müller V, Dall P et al. Subcutaneous Trastuzumab for HER2-pos-itive Breast Cancer – Evidence and Practical Experience in 7 German Cen-ters. Geburtshilfe Und Frauenheilkunde 2015; 75 (06): 566–73. DOI: 10.1055/s-0035-1546172
62. Inotai A, Csanadi M, Petrova G et al. Patient access, unmet medical need, ex-pected benefits, and concerns related to the utilisation of biosimilars in Eastern European Countries: a survey of experts. Biomed Res Int 2018; 2018: 9597362. PubMed PMID: 29546072.
63. Kawalec P, Stawowczyk E, Tesar T et al. Pricing and reimbursement of biosimilars in Central and Eastern European Countries. Front Pharmacol 2017; 8: 288. PMID: 28642700.
64. Fry AR, Krentz AJ, Hompesch M. Considerations in biosimilar insulin device development. Biosimilars 2016; 6: 9–15.
65. Polimeni G, Trifirò G, Ingrasciotta Y, Caputi AP. The advent of biosimilars for the treatment of diabetes: current status and future directions. Acta Dia-betol 2015; 52: 423–31.
66. Lalor F, Fitzpatrick J, Sage, C, Byrne E. Sustainability in the biopharmaceu-tical industry: Seeking a holistic perspective. Biotechnology Advances 2019. DOI: 10.1016/j.biotechadv.2019.03.015
2. Smolen JS, Landewé R, Bijlsma J et al. EULAR recommendations for the man-agement of rheumatoid arthritis with synthetic and biological disease-modify-ing antirheumatic drugs: 2016 update. Ann Rheumat Diseas 2017; 76 (6), 960–
77. DOI: 10.1136/annrheumdis-2016-210715
3. Heinemann L. Biosimilar Insulin and Costs. J Diabet Sci Technol 2015; 10 (2): 457–62. DOI: 10.1177/1932296815605337
4. European Medicines Agency. Guideline on similar biological medicinal prod-ucts (Rev. 1). Official Website of European Medicines Agency. 2014 (October 23). https://www.ema.europa.eu/en/documents/scientific-guideline/guide-line-similar-biological-medicinal-...
5. Дедов И.И., Шестакова М.В., Петеркова В.А. и др. Проект рекомендаций Российской ассоциации эндокринологов по применению биосимиляров инсулина. Сахарный диабет. 2021; 24 (1): 76–9.
[Dedov I.I., Shestakova M.V., Peterkova V.A. et al. Proekt rekomendatsii Rossi-iskoi assotsiatsii endokrinologov po primeneniiu biosimiliarov insulina. Sakharnyi diabet. 2021; 24 (1): 76–9 (in Russian)].
6. Malozowski S. Biosimilars. Arq Bras Endocrinol Metab 2011; 55 (8): 669–9. DOI: 10.1590/s0004-27302011000800025
7. Об утверждении «Правил проведения исследований биологических ле-карственных средств Евразийского экономического союза». Решение Совета ЕЭК от 3 ноября 2016 г. №89. URL: www.docs.cntd.ru (дата обра-щения: 05.09.2021).
[Ob utverzhdenii "Pravil provedeniia issledovanii biologicheskikh lekarstven-nykh sredstv Evraziiskogo ekonomicheskogo soiuza'. Reshenie Soveta EEK ot 3 noiabria 2016 g. №89. URL: www.docs.cntd.ru (data obrashcheniia: 05.09.2021) (in Russian)].
8. Сohen H, Beydoun D, Chien D et al. Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians. Adv Ther 2017; 33 (12): 2160–72. DOI: 10.1007/s12325-016-0431-5. Epub 2016 Oct 31. PMID: 27798772; PM-CID: PMC5126187
9. Шестакова М.В., Викулова О.К., Железнякова А.В. и др. Эпидемиология са-харного диабета в Российской Федерации: что изменилось за последнее десятилетие? Терапевтический архив. 2019; 91 (10): 4–13. DOI: 10.26442/00403660.2019.10.000364
[Shestakova M.V., Vikulova O.K., Zhelezniakova A.V. et al. Epidemiologiia sakharnogo diabeta v Rossiiskoi Federatsii: chto izmenilos' za poslednee desi-atiletie? Terapevticheskii arkhiv. 2019; 91 (10): 4–13. DOI: 10.26442/00403660.2019.10.000364 (in Russian)].
10. Шестакова М.В., Ефремова Н.В., Болотская Л.Л. и др. Сравнительный анализ эффективности гликемического контроля и частоты разви-тия микроангиопатий у пациентов с сахарным диабетом 1-го типа, получающих терапию генноинженерными инсулинами человека или аналогами инсулина человека: данные 10-летнего ретроспективного наблюдения. Сахарный диабет. 2016; 19 (5): 388–96. DOI: 10.14341/DM8050
[Shestakova M.V., Efremova N.V., Bolotskaia L.L. et al. Sravnitel'nyi analiz effek-tivnosti glikemicheskogo kontrolia i chastoty razvitiia mikroangiopatii u pat-sientov s sakharnym diabetom 1-go tipa, poluchaiushchikh terapiiu gen-noinzhenernymi insulinami cheloveka ili analogami insulina cheloveka: dan-nye 10-letnego retrospektivnogo nabliudeniia. Sakharnyi diabet. 2016; 19 (5): 388–96. DOI: 10.14341/DM8050 (in Russian)].
11. Демидова Т.Ю., Балутина О.В. Особенности высококонцентрированных инсулинов: основные характеристики и результаты исследований. Са-харный диабет. 2019; 22 (5): 481–90. DOI: 10.14341/DM10334
[Demidova T.Iu., Balutina O.V. Osobennosti vysokokontsentrirovannykh insuli-nov: osnovnye kharakteristiki i rezul'taty issledovanii. Sakharnyi diabet. 2019; 22 (5): 481–90. DOI: 10.14341/DM10334 (in Russian)].
12. Thalange N, Bereket A, Larsen J et al. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes 2011; 12 (7): 632–41. DOI: 10.1111/j.1399-5448.2010.00750.x
13. U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs – Hu-mulin R. Official website of the U.S. Food and Drug Administration. 1982 (Oc-tober 28). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018780
14. Ниязов Р.Р., Драницына М.А., Васильев А.Н., Гавришина Е.В. Биоаналоги: разработка и изучение с помощью современных биотехнологий. Сахар-ный диабет. 2020; 23 (6): 548–560. DOI: 10.14341/DM12576
[Niiazov R.R., Dranitsyna M.A., Vasil'ev A.N., Gavrishina E.V. Bioanalogi: razrabotka i izuchenie s pomoshch'iu sovremennykh biotekhnologii. Sakharnyi diabet. 2020; 23 (6): 548–560. DOI: 10.14341/DM12576 (in Russian)].
15. Reilly MS, Schneider PJ. Policy recommendations for a sustainable biosimilars market: lessons from Europe. GaBI Journal 2020; 9 (2): 76–83. DOI: 10.5639/gabij.2020.0902.013
16. Kyriakopoulos S, Kontoravdi C. Analysis of the landscape of biologically-de-rived pharmaceuticals in Europe: dominant production systems, molecule types on the rise and approval trends. Eur J Pharm Sci 2013; 48: 428–41. DOI: 10.1016/j.ejps. 2012.11.016
17. Климонтов В.В., Мякина Н.Е. Биосимиляры аналогов инсулина: что мы должны о них знать. Эффективная фармакотерапия. 2015; 7. eLIBRARY ID: 23239358
[Klimontov V.V., Miakina N.E. Biosimiliary analogov insulina: chto my dolzhny
o nikh znat'. Effektivnaia farmakoterapiia. 2015; 7. eLIBRARY ID: 23239358 (in Russian)].
18. Evans DB, Hsu J, Boerma T. Universal health coverage and universal access. Bull World Health Organ 2013; 91 (8): 546–6A. DOI: 10.2471/BLT.13.125450. PMID: 23940398; PMCID: PMC3738317
19. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther 2013; 93: 170–6.
20. Schiel JE, Mire-Sluis A, Davis D. Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials. ACS Symposium Series; American Chemical Society: Washington, DC. 2014. http://pubs.acs.org/DOI/Pdf/ 10.1021/bk-2014-1176.ch001
21. Global biosimilar insulin sales market report, 2021. URL: www.qyresearch.com
22. Официальный сайт ОО «Герофарм», Россия. URL: www.geropharm.ru/[Ofitsial'nyi sait OO "Gerofarm", Rossiia. URL: www.geropharm.ru/ (in Rus-sian)].
23. Федеральный закон «Об обращении лекарственных средств» №61-ФЗ от 12.04.2010 с дополнениями от 27.12.2019 «О внесении изменений в Федеральный закон “Об обращении лекарственных средств“ № 475-ФЗ». [Federal'nyi zakon "Ob obrashchenii lekarstvennykh sredstv' №61-FZ ot 12.04.2010 s dopolneniiami ot 27.12.2019 "O vnesenii izmenenii v Federal'nyi zakon “Ob obrashchenii lekarstvennykh sredstv“ № 475-FZ". (in Russian)].
24. Bui LA, Hurst S, Finch GL et al. Key considerations in the preclinical develop-ment of biosimilars. Drug Discov Today 2015; 20 (Suppl. 1): 3–15.
25. Camacho LH, Frost CP, Abella E et al. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med 2014; 3: 889–99.
26. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol 2008; 19: 411–9.
27. Ahmed I, Kaspar B, Sharma U. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 2012; 34: 400–19.
28. Mann M, Jensen ON. Proteomic analysis of post-translational modifications. Nat Biotechnol 2003; 21: 255–61.
29. Walsh G, Jefferis R. Post-translational modifications in the context of therapeu-tic proteins. Nat Biotechnol 2006; 24: 1241–52.
30. Li F, Vijayasankaran N, Shen AY et al. Cell culture processes for monoclonal an-tibody production. MAbs 2010; 2: 466–79.
31. Al-Sabbagh A, Olech E, McClellan JE, Kirchhoff CF. Development of biosimilars. Semin Arthritis Rheum 2016; 45: S11–8.
32. Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthri-tis Rheum 2015; 44: S2–8.
33. Liu HF, Ma J, Winter C et al. Recovery and purification process development for monoclonal antibody production. MAbs 2010; 2: 480–99.
34. Crutchlow MF, Palcza JS, Mostoller KM et al. Single-dose euglycaemic clamp studies demonstrating pharmacokinetic and pharmacodynamic similarity be-tween MK-1293 insulin glargine and originator insulin glargine (Lantus) in subjects with type 1 diabetes and healthy subjects. Diabetes Obes Metab 2018; 20 (2): 400–8. DOI: 10.1111/dom.13084
35. Kapitza C, Nowotny I, Lehmann A et al. Similar pharmacokinetics and pharma-codynamics of rapid-acting insulin lispro products SAR342434 and US- and EU-approved Humalog in subjects with type 1 diabetes. Diabetes Obes Metab 2017; 19 (5): 622–7. DOI: 10.1111/dom.12856
36. Майоров А.Ю., Драй Р.В., Каронова Т.Л. и др. Оценка биоподобия препа-ратов РинГлар® (ООО «Герофарм», Россия) и Лантус® («Санофи-Авен-тис Дойчланд ГмбХ», Германия) с использованием метода эугликеми-ческого гиперинсулинемического клэмпа у пациентов с сахарным диа-бетом 1-го типа: двойное слепое рандомизированное клиническое ис-следование. Сахарный диабет. 2020; 23 (4): 304–15. DOI: 10.14341/DM10095
[Maiorov A.Iu., Drai R.V., Karonova T.L. et al. Otsenka biopodobiia preparatov RinGlar® (OOO "Gerofarm', Rossiia) i Lantus® ("Sanofi-Aventis Doichland Gm-bKh', Germaniia) s ispol'zovaniem metoda euglikemicheskogo giperinsuline-micheskogo klempa u patsientov s sakharnym diabetom 1-go tipa: dvoinoe slepoe randomizirovannoe klinicheskoe issledovanie. Sakharnyi diabet. 2020; 23 (4): 304–15. DOI: 10.14341/DM10095 (in Russian)].
37. European Medicines Agency. Guideline on non-clinical and clinical develop-ment of similar biological medicinal products containing recombinant human insulin and insulin analogues. 2015 (February 26). EMEA/CHMP/BMWP/32775/2005_Rev. 1
38. Draft FDA guidance – Development of Therapeutic Protein Biosimilars: Com-parative Analytical Assessment and Other Quality-Related Considerations, May 2019.
39. О порядке определения взаимозаменяемости лекарственных препара-тов для медицинского применения. Постановление Правительства Российской Федерации от 05.09.2020 №1360. https://docs.cntd.ru/docu-ment/565687356 (дата обращения: 05.09.2021).
[O poriadke opredeleniia vzaimozameniaemosti lekarstvennykh preparatov dlia meditsinskogo primeneniia. Postanovlenie Pravitel'stva Rossiiskoi Feder-atsii ot 05.09.2020 №1360. https://docs.cntd.ru/document/565687356 (data obrashcheniia: 05.09.2021) (in Russian)].
40. Мосикян А.А., Бабенко А.Ю., Макаренко И.Е. Иммуногенность препара-тов инсулинов: краеугольный камень в оценке безопасности. РМЖ. 2019; 4: 32–7.
[Mosikian A.A., Babenko A.Iu., Makarenko I.E. Immunogennost' preparatov in-sulinov: kraeugol'nyi kamen' v otsenke bezopasnosti. RMZh. 2019; 4: 32–7 (in Russian)].
41. Strand V, Cronstein B. Biosimilars: How similar? Intern Med J 2014; 44 (3): 218–23. DOI: 10.1111/imj.12292
42. Mellstedt H. Anti-neoplastic biosimilars–the same rules as for cytotoxic gener-ics cannot be applied. Ann Oncol 2013; 24 (Suppl. 5): v23-8. http://www.ncbi.nlm.nih.gov/ pubmed/23975701
43. Paul S, Tedesco ED, Genin C, Roblin X. Review article: Biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther 2013; 38: 914–92.
44. Jeske W, Hoppensteadt D. Update on the safety and bioequivalence of biosimi-lars – focus on enoxaparin. Drug Healthc Patient Saf 2013; 5: 133–41.
45. Reunioes de reflexao da Revista Potuguesa de Farmacoterapia: Medicamentos Biossimilares. Rev Port Farmacoter 2013; 5.
46. Casadevall N, Edwards IR et al. Pharmacovigilance and biosimilars: Consider-ations, needs and challenges. Expert Opin Biol Ther 2013; 13 (7): 1039–47.
47. Нu X, Chen F. Exogenous insulin antibody syndrome (EIAS): a clinical syndrome associated with insulin antibodies induced by exogenous insulin in diabetic pa-tients. Endocr Connect 2018; 7 (1): R47-R55. DOI: 10.1530/EC-17-0309
48. Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products, 2014. http://www.fda.gov/Drugs/GuidanceComplianceRegulatory-Information/Guidances/default.htm
49. Кaronova TL, Mosikian AA, Mayorov AY et al. Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus®): a randomized open-label clinical trial. J Comp Eff Res 2020; 9 (4): 263–73. DOI: 10.2217/cer-2019-0136
50. Simoensa S, Vulto AG. A health economic guide to market access of biosimilars. Exp Opinion Biol Ther 2021; 21 (1): 9–17. DOI: 10.1080/14712598. 2021.1849132
51. Heredia E, Ribeiro A. Discount offered by first and subsequent biosimilars in the US, EU and LATAM: impact trends of originator starting price, market dynam-ics and regulations. Value Health 2018; 21 (Suppl. 1): S103–S104. DOI: 10.1016/j.jval.2018.04.700
52. Moorkens E, Vulto AG, Huys I et al. Policies for biosimilar uptake in Europe: An overview. PLOS ONE 2017; 12 (12): e0190147. DOI: 10.1371/journal. pone.0190147
53. Evaluate Pharma World Preview, 2019. Outlook to 2024. http://www.eval-uate.com/PharmaWorldPreview2019
54. Biosimilars in the United States 2020–2024 Competition, Savings, and Sus-tainability. IQVIA Institute Report. 2020 (Sep. 29). https://www.iqvia.com/en/insights/the-iqvia-institute/reports/biosimi-lars-in-the-united-states-2020...
55. Rognoni C, Bertolani A, Jommi C. Budget impact analysis of rituximab biosimilar in Italy from the hospital and payer perspectives. Glob Reg Health Technol Asse 2018; 20: 1–11.
56. Aladul MI, Fitzpatrick RW, Chapman SR. Impact of infliximab and etaner-cept biosimilars on biological disease-modifying antirheumatic drugs utili-sation and NHS budget in the UK. BioDrugs 2017; 31 (6): 533–544. PubMed PMID: 29127626.
57. Calleja-Hernández MA, Martínez-Sesmero JM, Santiago-Josefat B. Biosimi-lars of monoclonal antibodies in inflammatory diseases and cancer: current situation, challenges, and opportunities. Farm Hosp 2020; 44 (3): 100–8.
58. Sun D, Andayani TM, Altyar A et al. Potential cost savings from chemother-apy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European Union G5 countries: a simulation study. Clin Ther 2015; 37 (4): 842–57. DOI: 10.1016/ j.clinthera.2015.01.011
59. Abraham I, Han L, Sun D et al. Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries. Future Oncol 2014; 10 (9): 1599–609. DOI: 10.2217/fon.14.43
60. Franken MG, Kanters TA, Coenen JL et al. Potential cost savings owing to the route of administration of oncology drugs: a microcosting study of intra-venous and subcutaneous administration of trastuzumab and rituximab in the Netherlands. Anticancer Drugs 2018; 29 (8): 791–801. DOI: 10.1097/CAD.0000000000000648
61. Jackisch C, Müller V, Dall P et al. Subcutaneous Trastuzumab for HER2-pos-itive Breast Cancer – Evidence and Practical Experience in 7 German Cen-ters. Geburtshilfe Und Frauenheilkunde 2015; 75 (06): 566–73. DOI: 10.1055/s-0035-1546172
62. Inotai A, Csanadi M, Petrova G et al. Patient access, unmet medical need, ex-pected benefits, and concerns related to the utilisation of biosimilars in Eastern European Countries: a survey of experts. Biomed Res Int 2018; 2018: 9597362. PubMed PMID: 29546072.
63. Kawalec P, Stawowczyk E, Tesar T et al. Pricing and reimbursement of biosimilars in Central and Eastern European Countries. Front Pharmacol 2017; 8: 288. PMID: 28642700.
64. Fry AR, Krentz AJ, Hompesch M. Considerations in biosimilar insulin device development. Biosimilars 2016; 6: 9–15.
65. Polimeni G, Trifirò G, Ingrasciotta Y, Caputi AP. The advent of biosimilars for the treatment of diabetes: current status and future directions. Acta Dia-betol 2015; 52: 423–31.
66. Lalor F, Fitzpatrick J, Sage, C, Byrne E. Sustainability in the biopharmaceu-tical industry: Seeking a holistic perspective. Biotechnology Advances 2019. DOI: 10.1016/j.biotechadv.2019.03.015