The cost of diabetes care in the US is unaffordable for many, where list prices range from US$125 to more than US$500. One recent study [1] reported as many as 25% of patients under-using insulin due to the cost. The inaccessibility of insulin is therefore causing preventable ill health, disproportionately affecting groups that are un- or under-insured.

Insulin biosimilars are essential to reduce costs and increase accessibility, but barriers remain to market entry in the US [2]. To improve access, in March 2022 a consortium of large US hospitals announced plans to manufacture and sell their own biosimilar insulin. Prices will be capped at US$30 per vial and US$55 for five injector pen cartridges – significantly lower than what is currently available in the US.

The consortium is constructing a 140,000 sq ft manufacturing site in Petersburg, Virginia. After construction and obtaining US Food and Drug Administration (FDA) approval, the consortium plans to begin selling its generic insulin through non-profit company Civica Rx.

Civica say the facility will eventually have capacity to produce a substantial amount of the insulin needed in the US, with space to increase production if necessary. The estimated timeline for beginning sales is 2024.

In a statement, Civica say these new insulins will ‘benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses’, especially uninsured people who may pay very high out-of-pocket costs for insulin.

The initiative, which involves collaborations with a number of diabetes organizations including Blue Cross Blue Shield (BCBS) Association, independent BCBS companies, and several charities, will produce three biosimilar insulins: glargine (Lantus), lispro (Humalog) and aspart (Novolog). Each will be available in both vials and pre-filled pens.

A co-development and commercial agreement has been signed with GeneSys Biologics, a biopharmaceutical company based in Hyderabad, India, through which GeneSys will produce the drug substance and Civica will have exclusive rights in the US to market and sell the insulin products.

Board Chair of Civica, Dan Liljenquist, said: ‘Diabetes is arguably America’s most expensive chronic condition, and it is heartbreaking that millions of people are rationing their care and putting their lives at risk because they can no longer afford insulin. Through mission-driven partnerships, we are choosing to create a new market reality where no one is forced to ration essential diabetes medications’.

Martin VanTrieste, President and CEO of Civica Rx, added, ‘More than 8 million Americans rely on insulin to live, but many can’t afford to take the amount they need because of the historically high and prohibitive cost of insulin. We know that to really solve for the insulin cost and access challenges so many Americans face, we need a process – from manufacturing to setting a transparent price – that ultimately lowers the cost of the drug for those living with diabetes. In that spirit, we will ensure patients know where Civica’s low-cost insulin is available’.

Commenting on the alliance with Civica, Mr Rajender Rao, Chairman and Co-founder, GeneSys Biologics said, ‘GeneSys was founded with the objectives of developing and manufacturing quality biosimilars that deliver meaningful affordability and access to patients. The partnership with Civica will help us achieve these objectives in support of people living with diabetes’. Mr Venkat Reddy, Director, GeneSys Biologics, added, ‘This is a significant milestone for GeneSys to bring affordable insulin to U.S. consumers, and we are excited to partner with Civica in delivering on this shared mission’.
 
‘Bold philanthropic partners have made it possible, with committed funds to date of over two-thirds of our $125M goal, for us to undertake this affordable insulin initiative’, said Ken Boyden, Executive Director of the Civica Foundation. ‘We are incredibly grateful for their leadership. They each have a passion for and commitment to building pathways to reliable drug access and affordability’.

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References
1. Herkert D, Vijayakumar P, Luo J, et al. Cost-related insulin underuse among patients with diabetes. JAMA Intern Med. 2019;179(1):112-14.
2. GaBI Online - Generics and Biosimilars Initiative. The impact of insulin biosimilars on the diabetes landscape [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 1]. Available from: www.gabionline.net/biosimilars/research/the-impact-of-insulin-biosimilars-on-the-diabetes-landscape

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