Biosimilar of analogue of insulin glargin: proven safety, effectiveness, interchangeability

Diabetes mellitus (DM) is a global medical and social problem, its prevalence is steadily increasing throughout the world. The significance of DM is due to early disability and high mortality, primarily from macro- and microvascular complications of diabetes mellitus. Adequate therapy and its timely intensification in order to achieve an optimal individual level of glycemic control is an important aspect in this regard. Insulin therapy is indicated for all patients with type 1 diabetes mellitus. In type 2 diabetes the appointment of basal insulin is necessary if it is impossible to adequately control glycemia with oral drugs. Treatment of diabetes all over the world and in our country requires significant healthcare costs. The problem of reducing the cost of drug therapy in all countries of the world is currently being solved by the admission to the market of biosimilar drugs (biosimilars). A biosimilar (biosimilar) medicinal product (biosimilar, biosimilar) is a biological product similar in terms of quality, efficacy and safety to a reference biological medicinal product in the same dosage form and having an identical route of administration. Insulin glargine is one of the commonly used drugs in clinical practice and is of interest for reproduction. Biosimilar currently registered. This is a biosimilar of domestic production of insulin glargine with proven bio- and therapeutic equivalence, immune safety, good tolerance, recognized as interchangeable with the original insulin glargine. Indications and contraindications for use can be extrapolated to biosimilar without fear of reducing efficacy and the development of adverse events.

1. Verbovoy A.F., Pashentseva A.V., Verbovaya N.I. Diabetic macroangiopathy. Terapevticheskii Arkhiv. 2019;91(10):139–143. (In Russ.) https://doi.org/10.26442/00403660.2019.10.000109.

2. Avogaro A., Fadini G.P. Microvascular complications in diabetes: A growing concern for cardiologists. Int J Cardiol. 2019;(291):29–35. https://doi.org/10.1016/j.ijcard.2019.02.030.

3. Crasto W., Patel V., Davies M.J., Khunti K. Prevention of Microvascular Complications of Diabetes. Endocrinol Metab Clin North Am. 2021;50(3):431–455. https://doi.org/10.1016/j.ecl.2021.05.005.

4. Demidov N.A., Balberova M.A., Antsiferov M.B. What can affect the effectiveness of basal insulin therapy for patients with type 2 diabetes mellitus: analysis of the results of real clinical practice according to the diabetes register. Farmateka. 2019;26(14):60–66. (In Russ.) https://doi.org/10.18565/pharmateca.2019.14.60-66.

5. Bommer C., Heesemann E., Sagalova V., Manne-Goehler J., Atun R., Bärnighausen T., Vollmer S. The global economic burden of diabetes in adults aged 20–79 years: a cost-of-illness study. The lancet Diabetes & endocrinology. 2017;5(6):423–430. https://doi.org/10.1016/S2213-8587(17)30097-9.

6. Bommer C., Sagalova V., Heesemann E., Manne-Goehler J., Atun R., Bärnighausen T., Davies J., Vollmer S. Global Economic Burden of Diabetes in Adults: Projections From 2015 to 2030. Diabetes Care. 2018;41(5):963–970. https://doi.org/10.2337/dc17-1962.

7. Zhang P., Gregg E. Global economic burden of diabetes and its implications. Lancet Diabetes Endocrinol. 2017;5(6):404–405. https://doi.org/10.1016/S2213-8587(17)30100-6.

8. Dedov I.I., Omelyanovskiy V.V., Shestakova M.V., Avksentieva M.V., Ignatieva V.I. Diabetes mellitus as an economic problem in Russian Federation. Diabetes Mellitus. 2016;19(1):30–43. (In Russ.) https://doi.org/10.14341/DM7784.

9. Arinina E.E., Rashid M.A. Economical advantages of insulin analogues use in basal-bolus regimen for the therapy of type 1 diabetes mellitus. Pharmacoeconomics: Theory and Practice. 2017;5(1):47–51. (In Russ.) Available at: https://pharmacoeconom.com/netcat_files/367/577.Ekonomicheskie_preimuschestva_ispol_zovaniya_analogov_insulina.pdf.

10. Dremova N.B., Solomka S.V. World pharmaceutical market: trendwatching. Laboratory and Clinical Medicine. Pharmacy. 2022;2(1):56–68. (In Russ.) https://doi.org/10.14489/lcmp.2022.01.pp.056-068.

11. Davies M., Dahl D., Heise T., Kiljanski J., Mathieu C. Introduction of biosimilar insulins in Europe. Diabet Med. 2017;34(10):1340–1353. https://doi.org/10.1111/dme.13400.

12. Agirrezabal I., Sánchez-Iriso E., Mandar K., Cabasés J.M. Real-World Budget Impact of the Adoption of Insulin Glargine Biosimilars in Primary Care in England (2015-2018). Diabetes Care. 2020;43(8):1767–1773. https://doi.org/10.2337/dc19-2395.

13. Inotai A., Csanadi M., Petrova G., Dimitrova M., Bochenek T., Tesar T. et al. Patient access, unmet medical need, expected benefits, and concerns related to the uropation of biosimilars in Eastern European Countries: a survey of experts. Biomed Res Int. 2018;(2018):9597362. https://doi.org/10.1155/2018/9597362.

14. Kawalec P., Stawowczyk E., Tesar T., Skoupa J., Turcu-Stiolica A., Dimitrova M. et al. Pricing and reimbursement of biosimilars in Central and Eastern European Countries. Front Pharmacol. 2017;(8):288. https://doi.org/10.3389/fphar.2017.00288.

15. Ghosh S., Bose S., Gowda S., Mukhopadhyay P. Biosimilar insulins – What a clinician needs to know? Indian J Endocrinol Metab. 2019;23(4):400–406. https://doi.org/10.4103/ijem.IJEM_180_19.

16. Dunn C.J., Plosker G.L., Keating G.M., McKeage K., Scott L.J. Insulin glargine: an updated review of its use in the management of diabetes mellitus. Drugs. 2003;63(16):1743–1778. https://doi.org/10.2165/00003495-200363160-00007.

17. Rys P., Wojciechowski P., Rogoz-Sitek A., Niesyczyński G., Lis J., Syta A., Malecki M.T. Systematic review and meta-analysis of randomized clinical trials comparing efficacy and safety outcomes of insulin glargine with NPH insulin, premixed insulin preparations or with insulin detemir in type 2 diabetes mellitus. Acta Diabetol. 2015;52(4):649–662. https://doi.org/10.1007/s00592-014-0698-4.

18. Rezaei S., Taheri A., Taheri S., Kasirzadeh S., Fatemi B., Sorato M.M. Efficacy and safety of insulin detemir versus glargine in patients with diabetes: a systematic review and meta-analysis. Expert Rev Clin Pharmacol. 2022;15(6):767–777. https://doi.org/10.1080/17512433.2022.2078700.

19. Hilgenfeld R., Seipke G., Berchtold H., Owens D.R. The Evolution of Insulin Glargine and its Continuing Contribution to Diabetes Care. Drugs. 2014;74(8):911–927. https://doi.org/10.1007/s40265-014-0226-4.

20. Linnebjerg H., Lam E.C.Q., Seger M.E., Coutant D., Chua L., Chong C.L. et al. Comparison of the Pharmacokinetics and Pharmacodynamics of LY2963016 Insulin Glargine and EU- and US-Approved Versions of Lantus Insulin Glargine in Healthy Subjects: Three Randomized Euglycemic Clamp Studies. Diabetes Care. 2015;38(12):2226–2233. https://doi.org/10.2337/dc14-2623.

21. Ilag L.L., Deeg M.A., Costigan T., Hollander P., Blevins T.C, Edelman S.V. et al. Evaluation of immunogenicity of compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus. Diabetes Obes Metab. 2016;18(2):159–168. https://doi.org/10.1111/dom.12584.

22. Heise T., Donnelly C., Barve A., Aubonnet P. Pharmacokinetic and pharmaco-dynamic bioequivalence of proposed biosimilar MYL-1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2020;22(4):521–529. https://doi.org/10.1111/dom.13919.

23. Blevins T.C., Barve A., Sun B., Ankersen M. Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 1 diabetes after 52 weeks: Results of the INSTRIDE 1 phase III study. Diabetes Obes Metab. 2018;20(8):1944–1950. https://doi.org/10.1111/dom.13322.

24. Sun B., Sengupta N., Rao A., Donnelly C., Waichale V., Roy A.S., Ramaswamy S. et al. Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies. BMC Endocr Disord. 2021;21(1):129. https://doi.org/10.1186/s12902-021-00797-4.

25. Вlevins T.C., Barve A., Sun B., Raiter Y., Aubonnet P., Muniz R. et al. Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study. Diabetes Obes Metab. 2019;21(1):129–135. https://doi.org/10.1111/dom.13495.

26. Mayorov A.Y., Drai R.V., Karonova T.L., Avdeeva O.I., Makarenko I.E., Koksharova E.O. et al. Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi–Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double–blind randomized clinical trial. Diabetes Mellitus. 2020;23(4):304–315. (In Russ.) https://doi.org/10.14341/DM10095.

27. Karonova T.L., Mosikian A.A., Mayorov A.Y., Makarenko I.E., Zyangirova S.T., Afonkina O.A. 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):263–273. https://doi.org/10.2217/cer-2019-0136.

28. Yang L.J., Wu T.W., Tang C.H., Peng T.R. Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis. BMC Endocr Disord. 2022;22(1):35. https://doi.org/10.1186/s12902-022-00944-5.