Dive Insight:

More than 6 million people in the U.S. depend on insulin to treat their diabetes. But rising prices have caused an estimated 25% of patients to ration the medicine, according to one study.

Civica’s plan will reduce costs for patients by 85% to 90%, claimed Dan Liljenquist, an executive at Intermountain Healthcare who spearheaded the formation of Civica in 2018. “The annual per capita costs of insulin now exceed a whopping $6,000,” Liljenquist said in a post on LinkedIn. “This is unacceptable.”

The company’s plans align with Biden’s challenge to Congress to limit the out-of-pocket cost for insulin to $35 a month, the cap in a bill released last month by Sen. Raphael Warnock, D-Ga. Insulin costs only about $10 a vial to make, Biden said, so drugmakers can still do “very well” on profit margins.

Civica is working with GeneSys Biologics to develop the three insulin biosimilars, and will have exclusive rights to the products in the U.S. It plans to manufacture the medicines at a new 140,000-square-foot plant under construction in Petersburg, Virginia, currently slated to open in early 2024.

To achieve its goal, Civica has to succeed in a number of difficult tasks in a short amount of time. Beyond manufacturing, the company will have to complete clinical trials and make its way through the regulatory process at the Food and Drug Administration.

The agency recently moved to a new framework for approving copycat versions of insulin and only last year approved the first interchangeable biosimilar, a long-acting insulin from Viatris and Biocon. Before that, manufacturers were caught in a regulatory “dead zone” that discouraged applications.

Currently, Civica provides about 60 generic sterile injectable medicines to systems that collectively account for a third of the hospital beds in the U.S. The company said it’s pioneering the idea of a maximum consumer price for generic outpatient medicines. In addition to the $30 limit for vials, Civica said it will recommend a cap of $55 for a box of five pen cartridges for insulin.