|LETTER TO THE EDITOR
|Year : 2016 | Volume
| Issue : 4 | Page : 574-575
Biosimilar insulins: An unavoidable option in South-East Asia
Prashant Ulhas Kaduskar
Director, Prashant Diabetes and Endocrinology Center, Jalgaon, Maharshtra, India
|Date of Web Publication||3-Jun-2016|
Prashant Ulhas Kaduskar
Om Hospital, Vivekananad Nagar, Jalgaon - 425 001, Maharahstra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kaduskar PU. Biosimilar insulins: An unavoidable option in South-East Asia. Indian J Endocr Metab 2016;20:574-5
The editorial by Sanjay Kalra et al. focusing on various aspects of biosimilar insulin was quite an interesting reading. Diabetes management should be patient-centered, and financial constraint is one of the major determinants of diabetes treatment in South Asian countries. Biosimilar insulin may reduce the cost of diabetes treatment and also may increase the access of patients to diabetes care.
In the UK Prospective Diabetes Study trial, it was seen that by 9 years of diabetes duration 75% individuals require multiple therapies which may include insulin, and thus, the cost of diabetes management progressively increases. India has higher than the world average (9.1% vs. 8.3% worldwide) of diabetes, and the cost of diabetes drugs is 58% of total direct cost for households. The poor strata of people spend more on diabetes drugs compared to richer (75.4% vs. 65.9%). In India, as per one study, 45.3% diabetes patients were started on insulin therapy within 6 months of diagnosis if the target glycated hemoglobin was not achieved. Hence, there arises the need for cheaper medications and insulin.
The global insulin market is expected to reach in excess of $32 billion by 2018, with the sell of insulin glargine alone (Lantus ®; Sanofi-Aventis, Paris, France) in 2013 was worth~$7.5billion. In view of such a huge market, many companies are exploring the option of biosimilar insulin. Furthermore, a recent survey carried out in people with type 1 and type 2 diabetes suggested that the majority are willing to consider biosimilar insulins. However, many in this study were also worried about the quality and effectivity of such insulin. As manufacturers of biosimilar products do not have access to the cell line and technique of reference product, the manufacturing process may change slightly, but this may have tremendous impact on the biological function of the product, including immunogenicity, potentially affecting the safety and efficacy profile. Hence, regulatory requirement for the biosimilar drugs is stringent.
Presently, there is no position statement for introduction of biosimilars from European Association for the Study of Diabetes and the American Diabetes Association. However, Diabetes UK  released a statement in 2013 emphasizing that the decision about which insulin is most appropriate should always be made jointly between patients and their healthcare providers. A similar strategy for South East Asian patients seems logical. Patients should have complete access to the various information about biosimilar insulin such as efficacy, safety, immunogenicity, and various trials in the respective country. This will help the diabetes patient to make a well-informed decision regarding choosing biosimilar insulin as a treatment option.
Diabetes patient also needs to be educated regarding substitution and interchangeability of biosimilar insulin. Biosimilar product is considered interchangeable if it can be expected to produce the same clinical result as the reference product  in any given patient, whereas substitution occurs at the dispenser level. Interchangeability requires crossover studies with robust data and the decision rests with regional medical authority such as Food and Drug Administration. However, substitution should be done under medical supervision as switching from one type of product to other type from one type of biological to another will make evaluation of adverse events, in particular, causality (e.g., hypersensitivity or other immune-mediated reactions), difficult. Physicians need to be careful and can prevent pharmacy switching by writing on prescription as “dispense as written.”
Finally, a well-designed community health insurance scheme can improve access to medical care for poor people with diabetes as shown in one study. South Asian countries need to adopt health insurance schemes to lessen the cost of diabetes care. Such scheme would bring the cost of insulin further down and help physicians make the diabetes treatment patient-centric.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
American Dibetes Association. Standards of medical care in diabetes 2016. Diabetes Care 2016;39 Suppl 1:S1-111.
Dolinar RO, Edelman S, Heinemann L, Home P, Goyal S, Polonsky WH, et al.
Impact of biosimilar insulins on clinical practice: Meeting report. J Diabetes Sci Technol 2014;8:179-85.
Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: Progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999;281:2005-12.
Mahal A, Karan A, Engelgau M. The economic implications of non-communicable disease for India. Washington: World Bank; 2010.
Selvaraj S, Abrol D, Gopakumar KM. Access to Medicines in India. New Delhi, India: Academic Foundation; 2014.
Unnikrishnan AG, Wangnoo SK, Joshi SR, Banerjee S, Kumar A, Kalra S, et al.
Physician perceptions and practices in management of diabetes in India: Results from the IMPROVE control program. Indian J Endocrinol Metab 2012;16 Suppl 2:S428-9.
DeVries JH, Gough SCL, Kiljanski J, Heinmann L. Biosimilar insulins : A European perspective. Diabetes Obes Metab. 2015;17:445-451.
Wilkins AR, Venkat MV, Brown AS, Dong JP, Ran NA, Hirsch JS, et al.
Patient perspectives on biosimilar insulin. J Diabetes Sci Technol 2014;8:23-25.
Mukul Minocha and Jogarao Gobburu. Drug development and potential regulatory paths for biosimilars. J Diabetes Sci Technol. 2014;8:14-19. [Last accessed on 2016 Jan 21].
DeVries JH, Gough SC, Kiljanski J, Heinemann L. Biosimilar insulins: A European perspective. Diabetes Obes Metab 2015;17:445-51.
Devadasan N, Criel B, Van Damme W, Manoharan S, Sarma PS, Van der Stuyft P. Community health insurance in Gudalur, India, increases access to hospital care. Health Policy Plan 2010;25:145-54.
|This article has been cited by|
||Cross-sectional survey of biosimilar insulin utilization in Asia: The Joint Asia Diabetes Evaluation Program
| ||Linsey Gani,Eric Lau,Andrea Luk,Leorino Sobrepena,Quang Khanh Tran,Jothydev Kesavadev,Weiping Jia,Weinan Yu,Chiu Chi Tsang,Monojitketan Mukhopadhyay,Sujeet Jha,Wayne Sheu,Yoon Kun Ho,Thy Khue Nguyen,Risa Ozaki,Wing Yee So,Christine Kwan,Amy W C Fu,Roberto Mirasol,Sanjeev Ratnakar Phatak,Kanakatte Mylariah Prasanna Kumar,Sosale Aravind,Hari Janakiraman,Juliana C N Chan |
| ||Journal of Diabetes Investigation. 2018; |
|[Pubmed] | [DOI]|