The insulin market reaches 100

Biosimilar insulin concepts

“…Part of the impetus to the development of such products has been the high cost of insulin analogs, with the average price of rapid‐acting and long‐acting insulin analogs particularly high in the United States, between 8‐ and 20‐fold that in other developed countries, 14 costing nearly US$6000 per insulin‐treated person annually, with estimates that widespread availability of biosimilar insulin analogs could reduce this cost more than 50‐fold 15 . As a recent commentator observed, “The WHO added long‐acting analogues to its Essential Medicines List in its 2021 revision… Some people undoubtedly benefit from their use… Cost apart, there is no very good reason not to use them.” 1 …”

“…15 As a recent commentator observed, "The WHO added longacting analogues to its Essential Medicines List in its 2021 revision… Some people undoubtedly benefit from their use… Cost apart, there is no very good reason not to use them." 1 The US Food and Drug Administration (FDA) has suggested three levels of similarity that can be used in characterizing complex biologic pharmaceuticals such as insulin, with the goal of helping prescribers to offer appropriate biosimilar insulin analogs to people with diabetes treated with existing more expensive products. The FDA defines a follow-on biologic as one sufficiently similar to the original FDA-approved biologic to permit reliance on existing scientific knowledge about safety/ effectiveness, noting that this is determined on a case-bycase basis.…”

“…Insulin use has dramatically increased over the past 30 years, in part because of the increasing realization of its role in the treatment of type 2 diabetes (T2D) (Figure 1A ). 1 Worldwide, the prevalence of type 1 diabetes (T1D) is 0.95 per thousand persons, 2 for a total of approximately 7.5 million persons who require insulin in multiple daily dosages out of the world population of 7.9 billion. 3 In addition, an estimated 30.2 million persons with T2D are treated with insulin globally, using more than 500 billion units of insulin per year, 4 at a cost of some US$20 billion (Figure 1B ).…”

“…(B) Total annual insulin market value, $US billions, 1995–2020. Redrawn from data in 1 T1D, type 1 diabetes; T2D, type 2 diabetes…”