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The introduction of insulin analogues represented a major therapeutic advance for the expanding global diabetes population, improving quality of life for many people. Although the unit cost of insulin analogues is not as high as that of more complex biologics, such as monoclonal antibodies, the sheer number of patients with diabetes coupled with their need for lifelong treatment requires a financial commitment that many payers are unable to make. As a result, insulin analogues may be beyond the reach of many eligible patients. However, as some insulin analogues start to approach patent expiry, new manufacturers are able to begin developing less costly versions known as biosimilars. For regulatory approval, biosimilars need to demonstrate comparable safety and efficacy to the originator biologic in a head-to-head clinical trial.


Diabetes – a worldwide health crisis   +

There are 387 million people living with diabetes today1 – a number predicted to rise to 592 million by 2035.1 And despite being a generally manageable condition, diabetes was responsible for 4.9 million deaths globally in 2014.1 In the same year, global expenditure on diabetes care totalled USD $612 billion,2 compared to $500 billion only 4 years earlier.2 It is not unusual for families to spend 10–25% of their total income on diabetes care for a single adult or child.3
Insulin analogues have had a huge impact on diabetes care…   +

Despite the significant expansion of anti-diabetic therapies in recent years, insulin remains the mainstay of treatment for the world’s Type 1 population and for a growing proportion of patients with Type 2.4 The global insulin market was worth $20 billion in 2012 and, fueled by the rising prevalence of diabetes and the progressive nature of the disease, is expected to exceed $32 billion by 2019.5 The introduction of insulin analogues – both fast-acting and long-acting – has represented a major therapeutic advance for many patients. Formulated to overcome the disadvantages of synthetic human insulin,6 analogues allow for more flexible treatment regimens, help avoid weight gain and reduce hypoglycemic events.6,7 As well as improving patients’ quality of life and promoting medication adherence, reduction in hypoglycemic events cuts down hospital visits, which can sometimes offset treatment costs.8,9,10 There is also some evidence to suggest that optimal glycemic control may be more easily achievable with analogues. Recommended by the American Diabetes Association and the UK’s National Institute for Health and Care Excellence (NICE), insulin analogues are becoming increasingly desirable in diabetes care6,11 and one of them (insulin glargine) is currently the world’s top-selling diabetes medication.12
...but many patients can’t benefit because of the cost   +

However, the reality is that, around the world, millions of people with diabetes are unable to reap the benefits of modern research. The reason, of course, is cost. In some developing nations – where the cost of diabetes treatment can amount to 75% of a person’s annual income13 – insulin analogues may be out of reach for virtually the entire population. Even in developed nations, large discrepancies in patient access to insulin analogues exist.14,15,16 In some countries funding is generally made available but in others, patients who could greatly benefit from insulin analogues have to struggle with prohibitive out-of-pocket costs. Added to this is the cost of treatment for prophylactic medications commonly recommended for people with diabetes, the cost of treatment for the many co-morbidities and complications of the condition, and the costs of necessary equipment such as glucose monitors and testing strips.

Patent expiry permits introduction of less costly biologics known as biosimilars   +

The price of insulin analogues – which are biologics – reflect the scientific innovation and the investment required to support biotechnological research and development. But it puts them beyond the reach of many people. Pursuit of innovative new drugs is clearly of great importance, but so is broadening patient access to the treatments we have now.

Diabetes quotes

There’s no quick-fix solution – but, as some insulin analogues start to approach patent expiry, the opportunity arises for new manufacturers to develop less costly versions of them, which are most commonly known as biosimilars.* A biosimilar version of insulin glargine has already been approved in the EU, the US, Japan, and Australia.


*also known as follow-on biologics, subsequent-entry biologics and biocomparables, among others

What are biosimilars?   +

Unlike the generics of the chemical drug world, biosimilars are not exact copies of originator biologics, as it is not possible for a new manufacturer to precisely replicate the highly complex and sophisticated production processes. However, extensive regulatory requirements are designed to ensure that candidate biosimilars must be rigorously compared with their originators both analytically and clinically, to establish that quality, efficacy, and safety are all a very close match. By January 2016, 22 biosimilars in a range of therapy areas had been launched in Europe with no adverse clinical consequences compared with their originators21,22 – and have resulted in significant cost savings.23

The extent of the testing required means that biosimilars can’t be as heavily discounted as chemical generics. The average savings are projected to be 20–30%,24 but they could well be higher. For an insulin analogue, which can cost $270 per single vial, these savings are highly worthwhile, especially as patients will require lifelong treatment.25 In addition, the introduction of competition might prompt the manufacturers of originator insulin analogues to reduce their prices and to consider investing in innovative new products as they seek new competitive advantages. 

Although biosimilars are eagerly awaited in other therapeutic areas such as cancer and autoimmune disease, the sheer size of the global diabetes population suggests that this is where biosimilars may make the greatest economic impact. Biosimilar insulin products, together with biosimilar monoclonal antibodies, are already predicted to account for 57% of the global biosimilars market by 2023.26

Learn more about BiosimilarsRegulatory Requirements, and Biosimilars by Region.

Become a clinical investigator for biosimilar insulin analogues   +

Quintiles is actively supporting the development of biosimilar insulin analogues and we invite you to join us as a clinical investigator. The patients you enroll in these studies will all receive active therapy, either with a branded biologic or a biosimilar candidate at no cost to them or to their insurers. Even if you perceive that patient access to insulin analogues is not a critical issue in your own country, getting involved in biosimilar clinical trials will give you the opportunity to help maintain the high standards required for biosimilar studies, gain experience in an area of research projected to expand significantly, and be part of a global mission to bring the benefits of modern diabetes treatment to a far wider population.


Learn more about working with Quintiles.

Why partner with Quintiles?   +

  • We’ve worked with tens of thousands of clinical research sites worldwide since 1982
  • We helped to develop or commercialize all of the top 50 best-selling biotechnology products or compounds of 2013 
  • We’ve supported the development of biosimilars for more than 10 different originator biologics including monoclonal antibodies 
  • We established Biosimilars Knowledge Connect in 2012 to educate and engage investigators in biosimilar research
References   +

1. International Diabetes Federation. IDF Diabetes Atlas sixth edition (2014 Update Atlas poster). http://www.idf.org/sites/default/files/Atlas-poster-2014_EN.pdf. Accessed 28 January 2015.
2. World Economic Forum. Harvard School of Public Health. The global economic burden of non-communicable diseases. http://www3.weforum.org/docs/WEF_Harvard_HE_GlobalEconomicBurdenNonCommunicableDiseases_2011.pdf. Accessed 28 January 2015.
3. World Health Organization. Diabetes: The cost of diabetes, fact sheet no. 236. http://www.who.int/mediacentre/factsheets/fs236/en/. Accessed 28 January 2015.
4. Vimalavathini R, Agarwal SM & Gitanjali B. Educational program for patients with type-1 diabetes mellitus receiving free monthly supplies of insulin improves knowledge and attitude, but not adherence. Int J Diabetes Dev Ctries (2008) 28:86–90. 
5. MarketWatch, 25 July 2014. Global insulin market expected to reach USD 32.24 billion globally in 2019: Transparency Market Research. http://www.marketwatch.com/story/global-insulin-market-expected-to-reach-usd-3224-billion-globally-in-2019-transparency-market-research-2014-07-25. Accessed 28 January 2015.
6. Diabetes UK. Analogue insulin (Feb 2012). http://www.diabetes.org.uk/About_us/What-we-say/Medication-medical-devices-monitoring/Analogue-insulin/. Accessed 28 January 2015.
7. White JR, Davis SN, Cooppan R et al. Clarifying the role of insulin in type 2 diabetes management. Clin Diabetes (2003) 21:14–21.
8. Grunberger G. Insulin analogs—are they worth it? Yes! Diabetes Care (2014) 37:1767–1770.
9. Hartman I. Insulin analogs: Impact on treatment success, satisfaction, quality of life, and adherence. Clin Med Res (2008) 6:54–67.
10. US Pharmacist, 22 December 2006. Pharmacoeconomic advantages of insulin analogs. http://www.uspharmacist.com/content/d/featured_articles/c/11487/. Accessed 28 January 2015.
11. American Diabetes Association. Approaches to glycemic treatment. Sec. 7. Standards of medical care in diabetes 2015. Diabetes Care (2015) 38(Suppl. 1):S41–S48.
12. Rotenstein LS, Ran N, Shivers JP et al. Opportunities and challenges for biosimilars: what’s on the horizon in the global insulin market? Clin Diabetes (2012) 30:138–150.
13. 100 Campaign. 100 Campaign: insulin access by 2022. http://www.100campaign.org/. Accessed 28 January 2015.
14. Smokovski I. The challenge of diabetes treatment in Macedonia. EPMA J (2014) 5(Suppl 1):A68.
15. Only Medics. New forecasts predict 3.8% growth of type 2 diabetes’ European sales. http://www.onlymedics.com/news/17-02-2014/184/New+Forecasts+Predict+3.8%25+Growth+of+Type+2+Diabetes%E2%80%99+European+Sales. Accessed 28 January 2015.
16. Mayo Clinic, 31 July 2013. Living with diabetes blog. Insulin: Weighing the costs of technology. http://www.mayoclinic.org/diseases-conditions/diabetes/expert-blog/insulin-technology/bgp-20056484. Accessed 28 January 2015.
17. International Diabetes Federation. Health economics. http://www.idf.org/health-economics. Accessed 28 January 2015.
18. Canadian Diabetes Association. The burden of out-of-pocket costs for Canadians with diabetes. http://www.diabetes.ca/CDA/media/documents/publications-and-newsletters/advocacy-reports/burden-of-out-of-pocket-costs-for-canadians-with-diabetes.pdf. Accessed 28 January 2015.
19. Health Day, 10 June 2014. Insulin use, out-of-pocket costs way up for Type 2 diabetes. http://consumer.healthday.com/diabetes-information-10/insulin-news-414/insulin-use-out-of-pocket-costs-way-up-for-type-2-diabetes-688707.html. Accessed 28 January 2015.
20. Medical Chronicle, 5 October 2010. Diabetes burden shifts to developing world. http://www.medicalchronicle.co.za/diabetes-burden-shifts-to-developing-world/. Accessed 28 January 2015.
21. Ebbers HC, Crow SA, Vulto AG & Schellekens H. Interchangeability, immunogenicity and biosimilars. Nature Biotechnol (2012) 30:1186–1190.
22. McCamish M & Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther (2012) 91:405–417.
23. Rovira J, Espín J, García L & Olry de Labry A, 2011. The impact of biosimilars’ entry in the EU market. Andalusian School of Public Health.
24. PharmTech, 30 September 2014. New report details players and pipelines in the biosimilar space. http://www.pharmtech.com/pharmtech/News/New-Report-Details-Players-and-Pipelines-in-the-Bi/ArticleStandard/Article/detail/855810. Accessed 30 January 2015.
25. MedPageToday,9 November 2014. Price tag on old insulin skyrockets. http://www.medpagetoday.com/Endocrinology/Diabetes/47603. Accessed 28 January 2015.
26. Visiongain. Biosimilar drug revenues will reach $2,445m worldwide in 2013, predicts new Visiongain report. https://www.visiongain.com/Press_Release/407/Biosimilar-drug-revenues-will-reach-2-445m-worldwide-in-2013-predicts-new-visiongain-report. Accessed 28 January 2015.
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