Biosimilar insulin glargine: a solution for affordable and equitable diabetes care

Authors

  • Harish Kumar Department of Endocrinology, Amrita Institute of Medical Science, Cochin, Kerela, India
  • Jayashree Gopal Department of Endocrinology, Diab Endo India, Chennai, Tamil Nadu, India
  • Paramesh Shamanna Department of Endocrinology, Bangalore Diabetes Centre, Bangalore, Karnataka, India
  • Dhruvi Hasnani Department of Endocrinology, Rudraksha Institute of Medical Sciences, Ahmedabad, Gujarat, India
  • Vipul Chavda Department of Endocrinology, Rudraksha Institute of Medical Sciences, Ahmedabad, Gujarat, India
  • Hiren Prajapati Department of Medical Affairs, Eris Lifesciences Limited, Ahmedabad, Gujarat, India
  • Hardik V. Papaiya Department of Medical Affairs, Eris Lifesciences Limited, Ahmedabad, Gujarat, India

DOI:

https://doi.org/10.18203/2349-3933.ijam20261888

Keywords:

Diabetes mellitus, Biosimilar insulin glargine, Affordability, Accessibility

Abstract

Over past decades, insulin therapy has been a cornerstone in reshaping diabetes care from a chronically morbid disease into a manageable condition. Despite availability of multiple pharmacological therapies, diabetes patients still suffer from optimum glycaemic control especially fasting hyperglycaemia which further increase the risk of developing vascular complications. Basal insulin is a choice of medication when patients require fasting blood glucose control to achieve desired glycaemic goal. With such crucial need of basal insulin therapy for controlling fasting hyperglycaemia, it remains inaccessible for majority of patients in need. This challenge is more prevalent in low- and middle-income countries where need for insulin is rising as prevalence of diabetes increases. Biosimilar insulin has arisen as an important strategy to bridge this gap. This review addresses the outline of evolution of basal insulin therapy, especially biosimilar insulin glargine as a solution to overcome fasting hyperglycaemia. One such illustration is of biosimilar insulin glargine (BASALOG®, BIOCON) for which evidence from global clinical trials and real-world studies has demonstrated its safety, efficacy and immunogenicity comparable to the reference insulin glargine available. This has further led to the approval for biosimilar insulin glargine overseas including interchangeability designation by USFDA. Further this review underlines the Indian perspective regarding biosimilar insulin glargine affordability and adoption with emphasis on patient education, cold-chain management to increase access and real-world data generation. Collectively, biosimilar insulin glargine offers a scalable and sustainable model which has potential to expand access of basal insulin therapy to patients who are in need.

References

Polyzos SA, Mantzoros CS. Diabetes mellitus: 100 years since the discovery of insulin. Metabolism. 2021;118:154737.

Kramer CK, Retnakaran R, Zinman B. Insulin and insulin analogs as antidiabetic therapy: A perspective from clinical trials. Cell Metab. 2021;33:740-7.

Saad MA, Masood SN, Al Bache N, Odhaib SA, Belkhadir J, Shegem N. Accessibility and Availability of Insulin: A Survey by International Diabetes Federation-Middle East and North Africa Region (IDF-MENA) Member Associations. J Diabetol. 2022;13:S73.

Gkrinia EMM, Faour AK, Belančić A, Bazile J, Marland E, Vitezić D, et al. A Systematic Review of Economic Evaluations of Insulin for the Management of Type 2 Diabetes. Diabetology. 2023;4:440-52.

Knox R. Insulin insulated: barriers to competition and affordability in the United States insulin market. J Law Biosci. 2020;7:lsaa061.

Heinemann L, Davies M, Home P, Forst T, Vilsbøll T, Schnell O. Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials. J Diabetes Sci Technol. 2022;17:1649-61.

Matli MC, Wilson AB, Rappsilber LM, Sheffield FP, Farlow ML, Johnson JL. The First Interchangeable Biosimilar Insulin: Insulin Glargine-yfgn. J Diabetes Sci Technol. 2021;17:490-4.

Lee SH, Yoon KH. A Century of Progress in Diabetes Care with Insulin: A History of Innovations and Foundation for the Future. Diabetes Metab J. 2021;45:629-40.

Brink SJ. Insulin Past, Present, and Future: 100 Years from Leonard Thompson. Diabetology. 2022;3:117-58.

Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE. The Evolution of Insulin and How it Informs Therapy and Treatment Choices. Endocr Rev. 2020;41:733-55.

Landgraf W, Sandow J. Recombinant Human insulins clinical efficacy and safety in diabetes Therapy. Eur Endocrinol. 2016;12:12-7.

Hilgenfeld R, Seipke G, Berchtold H, Owens DR. The Evolution of Insulin Glargine and its Continuing Contribution to Diabetes Care. Drugs. 2014;74:911-27.

Wang Y, Zhou Y, Ding J, Li X, Guo F, Zhang J, et al. Pharmacokinetic and pharmacodynamic similarity evaluation between an insulin glargine biosimilar product and Lantus® in healthy subjects: Pharmacokinetic parameters of both parent insulin glargine and M1 were used as endpoints. Front Pharmacol. 2022;13:962201.

Kalra S, Kalra P, Gangopadhyay KK, Julka S, Lakhani OJ, Chawla M, et al. Expert Opinion on Optimizing Suboptimal Basal Insulin Titration in India: Addressing Challenges and Leveraging Digital Solutions. Diabetes Ther. 2025;16:1327-39.

Battelino T, Bosnyak Z, Danne T, Mukherjee B, Edelman S, Pilorget V, et al. InRange: comparison of the second-generation basal insulin analogues glargine 300 U/ml and degludec 100 U/ml in persons with type 1 diabetes using continuous glucose monitoring—study design. Diabetes Ther. 2020;11:1017-27.

Scott Morton FM, Stern AD, Stern S. The Impact of the Entry of Biosimilars: Evidence from Europe. Rev Ind Organ. 2018;53:173-210.

Pineda C, Caballero-Uribe CV, De Oliveira MG, Lipszyc PS, Lopez JJ, Mataos Moreira MM, et al. Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view. Clin Rheumatol. 2015;34:635-40.

Knezevic I, Griffiths E. Biosimilars global issues, national solutions. Biologicals. 2011;39:252-5.

Rezk MF, Pieper B. Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect. Rheumatol Ther. 2017;4:209-18.

In brief: Biologics and biosimilars. In: InformedHealth.org. Institute for Quality and Efficiency in Health Care (IQWiG). 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK499546/. Accessed on 23 January 2026.

Ghosh S, Bose S, Gowda S, Mukhopadhyay P. Biosimilar insulins what a clinician needs to know?. Indian J Endocrinol Metab. 2019;23:400.

Owens DR, Landgraf W, Schmidt A, Bretzel RG, Kuhlmann MK. The emergence of biosimilar insulin preparations a cause for concern?. Diabetes Technol Ther. 2012;14:989-96.

Dispelling Doubts: Review Affirms Safety, Efficacy of Biosimilar Insulins. Center for Biosimilars. 2025. Available at: https://www.centerforbiosimilars.com/view/dispelling-doubts-review-affirms-safety-efficacy-of-biosimilar-insulins. Accessed on 23 January 2026.

Nupur N, Joshi S, Gulliarme D, Rathore AS. Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms. Front Bioeng Biotechnol. 2022. Available at: https://www.frontiersin.org/journals/bioengineering-andbiotechnology/articles/10.3389/fbioe.2022.832059/full. Accessed on 23 January 2026.

Rathore A. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India. PDA J Pharm Sci Technol. 2012;66:393.

Japanese approval for insulin glargine biosimilar. 2015. Available at: https://www.gabionline.net/biosimilars/news/Japanese-approval-for-insulin-glargine-biosimilar. Accessed on 23 January 2026.

Biologics B. Biocon’s* Partner Mylan Receives Favourable Ruling from U.S. PTAB on Sanofi’s Four Device Patents for Lantus® SoloSTAR®. Biocon Biologics. 2020. Available at: https://www.bioconbiologics.com/biocons-partner-mylan-receives-favourable-ruling-from-u-s-ptab-on-sanofis-four-device-patents-for-lantus-solostar/. Accessed on 23 January 2026.

EMA approval for biosimilar insulin glargine Semglee. 2018. Available at: https://www.gabionline.net/biosimilars/news/EMA-approval-for-biosimilar-insulin-glargine-Semglee. Accessed on 23 January 2026.

USFDA. FDA approves first interchangeable biosimilar insulin product for treatment of diabetes. FDA News Release. Silver Spring (MD): U.S. Food and Drug Administration. 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes. Accessed on 23 January 2026.

White J, Goldman J. Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability. J Pharm Technol JPT Off Publ Assoc Pharm Tech. 2019;35:25-35.

Heise T, Donnelly C, Barve A, Aubonnet P. Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL-1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2020;22:521-9.

Kumar KP, Chowdhury S, Bantwal G, Unnikrishnan AG, Kalra S, Aggarwal S, et al. Insulin access enhancement in India: expert views on integrating interchangeable biosimilar insulin glargine. Cureus. 2024;16(5):e60983.

Blevins TC, 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;20:1944-50.

Blevins TC, 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;21:129-35.

Yang A, Yu J, Cheung JTK, Chan JCN, Chow E. Real world evidence of insulin and biosimilar insulin therapy—Opportunities to improve adherence, outcomes and cost‐effectiveness. Diabetes Obes Metab. 2025;27:45-62.

Blevins TC, Barve A, Raiter Y, Aubonnet P, Athalye S, Sun B, et al. Efficacy and safety of MYL-1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study. Diabetes Obes Metab. 2020;22:365-72.

Praveen R, Saboo B, Gadve S, Chopra V, Reddy S, Ramanathan B, et al. Switching from reference glargine (Lantus) to biosimilar glargine (Basalog) in T2DM patients uncontrolled on OADs. Diabetes Res Clin Pract. 2024;209:111260.

Christofides EA, Puente O, Norwood P, Denham D, Maheshwari H, Lillestol M, et al. Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan and Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks’ treatment: a randomized open-label study. Diabetes Obes Metab. 2024;26:2412-21.

Ewen M, Joosse HJ, Beran D, Laing R. Insulin prices, availability and affordability in 13 low-income and middle-income countries. BMJ Glob Health. 2019;4(3):e001410.

Reddy A. Diabetes and the WHO Model List of Essential Medicines. Lancet Diabetes Endocrinol. 2022;10(1):20-1.

Beran D, Ewen M, Laing R. Constraints and challenges in access to insulin: a global perspective. Lancet Diabetes Endocrinol. 2016;4:275-85.

Cefalu WT, Dawes DE, Gavlak G, Goldman D, Herman WH, Van Nuys K, et al. Insulin Access and Affordability Working Group: Conclusions and Recommendations. Diabetes Care. 2018;41:1299-311.

Owens, Griffiths S. Insulin Glargine (lantus®). Int J Clin Pract. 2002;56:460-6.

Morolla D, Beran D, Ewen M, Raviglione M, Von Schoen-Angerer T. Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries. BMJ Open. 2025;15:e090484.

Monga A, Gagan, Jamwal P, Sharma S, Kaur A. Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications. AAPS PharmSciTech. 2025;26:46.

Biocon Biologics. Biocon’s global biosimilars portfolio insulin glargine. Bengaluru (India): Biocon Biologics Ltd. 2025. Available at: https://www.bioconbiologics.com/businesses/biosimilars/insulin-glargine/. Accessed on 23 January 2026.

Oskouei ST, Kusmierczyk AR. Biosimilar Uptake: The Importance of Healthcare Provider Education. Pharm Med. 2021;35:215-24.

Bhatnagar A, Gupta V, Tandon P, Saksena T, Ranjan A, Gandhi P, et al. Last mile delivery of cold chain medicines – challenges and recommendations. Indian J Pharm Biol Res. 2018;6(1):34-41.

Downloads

Published

2026-06-20

How to Cite

Kumar, H., Gopal, J., Shamanna, P., Hasnani, D., Chavda, V., Prajapati, H., & Papaiya, H. V. (2026). Biosimilar insulin glargine: a solution for affordable and equitable diabetes care. International Journal of Advances in Medicine, 13(4), 251–257. https://doi.org/10.18203/2349-3933.ijam20261888

Issue

Section

Review Articles