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.
International Diabetes Federation: "Diabetes is causing economic havoc to those living with the disease, their families and ultimately whole countries, threatening economic development."17
USA: "Because of the expense, I've seen people with diabetes ration their insulin or go without it to make an insulin vial last longer, thus negetively affecting their blood glucose control and, ultimately, their overall health and survival."16
WHO: "Studies in India estimate that, for a low-income Indian family with an adult with diabetes, as much as 25% of family income may be devoted to diabetes care."3
Canada: "57% of Canadians with diabetes say they do not comply with their prescribed therapy because they cannot afford their medications, devices and supplies, thus potentially compromising their diabetes management."18
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.
"We spent $21 billion on glucose-lowering therapies and monitoring in 2010... That's a lot of money. But we spent $71 billion on hospital care. Right now, treating people with medication is less than one-third of the cost of treating their complications in the hospital."
Dr Robert Ratner, American Diabetes Association (ADA)
Chief Scientific and Medical Officer19
"It's an outrage that while treatment and technology exists for people with diabetes to manage their disease, the reality is that for millions of people in many countries, modern treatment and technology is still a dream."
Prof. Jean Claude Mbanya,
International Diabetes Federation (IDF) President, 2009–201220
There’s no quick-fix solution – but, as some insulin analogues start to approach patent expiry, the opportunity arises for new manufacturers to develop more affordable biosimilars. Biosimilar versions of insulin glargine have already been approved in the EU, the US, Canada, Japan, and Australia.
QuintilesIMS 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.