Study: Biosimilars Could Drastically Reduce the Cost of Insulin

Despite the fact that insulin is indispensable for approximately 100 million people with diabetes worldwide, an estimated half of those patients have no reliable supply of insulin, due in large part to cost.

A study newly published in BMJ Global Health sought to assess the cost to produce insulin and to examine how biosimilar insulin, if manufactured on a large scale, could reduce the cost of treatment for patients with diabetes.

The investigators designed formulae for estimating competitive—but profitable—prices for biosimilar insulin using the cost of an active pharmaceutical ingredient (API) and excipients either exported from India or based on quotes from biosimilar manufacturers, the cost of formulation into vials, development and regulatory costs, and a margin for operating expenses and profit.

Read more about high insulin costs.

Given the figures available, the authors calculated an estimated cost of production per vial of $1.45 to $9.64. They then arrived at the following estimated prices for biosimilar insulin treatment (in vial presentation) per patient per year:

• Regular human insulin: $48 to $71
• Neutral protamine Hagedorn insulin: $49 to $72
• Insulin glargine: $78 to $108
• Insulin lispro: $95 to $130
• Insulin aspart: $95 to $129
• Insulin glulisine: $94 to $128
• Insulin detemir: $283 to $365
• Insulin degludec: $98 to $133

Worldwide, current prices are far higher. Given government procurement prices for these drugs in multiple nations, including the United States (where insulins are regulated as drugs and not as biologics, and where subsequent-entry products are treated as follow-ons, rather than biosimilars), prices for regular human insulin are a median of 1.2 to 1.8 times the estimated prices, and current prices of insulin glargine, insulin lispro, and insulin aspart are a median of 5.6 to 7.8, 2.7 to 3.7, and 2.6 to 3.5 times higher, respectively, than the estimated biosimilar prices.

“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors.

The authors also note that prices could go even lower, as prices for APIs are falling: “Even at the low volumes currently being exported from India, the linear regression models showed 18% yearly decrease in price for exported human insulin API and 27% yearly decrease for insulin glargine. It would be reasonable to expect that with increasing biosimilar production, API prices will continue to fall.”

The authors call for national policies—such as tenders and special incentives—to spur biosimilar competition among multiple competitors and to help generate these substantial cost savings for health systems and for patients with diabetes.

Reference

Gotham D, Jarber MJ, Hill A. Production costs and potential prices for biosimilars of human insulin and insulin analogues. BMJ Glob Health. 2018;3(5):e000850. doi: 10.1136/bmjgh-2018-000850.