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.
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.
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
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
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.