By Zachary Brennan
March 3, 2022
As millions of insulin-dependent Americans have seen their out-of-pocket costs soar over the last few years, the market controlled by the three big insulin manufacturers — Sanofi, Eli Lilly and Novo Nordisk — is ripe for disruption.
And that’s just what nonprofit generic drugmaker Civica is looking to do, with plans to manufacture and market three of the most common forms of insulin: glargine, lispro and aspart. Perhaps most importantly, the company says it plans to set the price of each insulin to the consumer at no more than $30 per vial and no more than $55 for a box of five pen cartridges.
According to GoodRx, the cheapest insulin glargine vial is about $125, while the cheapest insulin lispro vial is about $360, and the cheapest insulin aspart pack of 5 pens is about $90. Although depending on a patient’s insurance, out-of-pocket costs can vary.
“Let’s cap the cost of insulin at $35 a month,” President Joe Biden said at the State of the Union this week. The idea has mustered some congressional support but a bill has yet to pass the House or Senate. Unlike the Biden plan, the Civica insulin prices will help those who are uninsured too.
“Our efforts will reduce insulin’s list price between 85% to 90%, where a patient can save thousands of dollars annually,” Civica CEO Martin VanTrieste said. The company is working with India-based GeneSys Biologics to develop the products.
GeneSys will make the active drug substance, and Civica will file the biologics license applications with the FDA, Allan Coukell, head of policy at Civica, told Endpoints News.
Civica will also complete the manufacturing process in-house, at its planned 140,000 square-foot manufacturing plant in Petersburg, Virginia, which is expected to be operational in early 2024.
The $125 million finished dosage (vials and pre-filled syringes) manufacturing plant will include disposable tech and filling lines to produce 90 million vials and 50 million pre-filled syringes annually, the company said, or enough for about 50 million patients per year.
Contingent on FDA approval of the insulin biosimilars, Civica anticipates that its first insulin glargine will be available for purchase as soon as early 2024. Ultimately, the company says it will have the capacity to produce “a substantial amount of the insulin needed in the United States,” with additional space to increase production if necessary.
Outside of insulin, Civica Rx, which launched with $100 million from 7 healthcare systems and 3 philanthropies, currently provides about 60 generic sterile injectable medicines in various dosage forms to over 55 hospital systems.
Back in January 2020, Civica also established a 7-year relationship with Thermo Fisher Scientific that’s initially focused on supplies of 9 critical drugs that are either in shortage or might soon run into a shortage.