Civica to Make California’s Own Insulin Brand

This content originally appeared on diaTribe. Republished with permission.

By Natalie Sainz

California Gov. Gavin Newsom announced a $50-million contract with Civica Rx to produce the state’s own insulin, adding to the recent new policies aiming to make this essential drug more affordable.

California Gov. Gavin Newsom’s announcement of his state’s contract with Civica Rx, a nonprofit generic drug company, is the latest in a flurry of announcements this year responding to the urgent need to lower insulin prices in the US.

Under the contract, California would produce its own insulin in an attempt to further bring down the cost of the drug nationwide.

California will work with Civica Rx under the CalRx Biosimilar Insulin Initiative to develop a biosimilar version of the three most popular insulin medications: one long-acting (glargine) and two rapid-acting products (aspart and lispro) in both vial and pen form. The branded versions of these biosimilar medications are popular ones like Lantus, Humalog, and Novolog.

Biosimilar drugs are approved if they demonstrate the same clinical effects and safety as the original product. You can learn more about biosimilar medications here.

Civica has announced that the suggested retail price for a 10mL vial of insulin will be no more than $30, and a 5-pack of 3mL pens will be no more than $55. Civica will develop the insulin medications under two labels: “CalRx” will be sold within California, and “CivicaRx” will be sold across the country, as soon as next year, according to the plan. They will be the same insulin but due to legislative requirements, the labels on the bottle will vary depending on where the insulins are shipped.

“The prices announced for CalRx-branded insulins are reflective of the actual costs to manufacture insulin, including distribution and pharmacy dispensing,” said Robin Figueroa, CalRx Biosimilar Insulin Program manager.

Newsom first introduced the CalRx Initiative in 2020, positioning California as the first state to produce its own generic drugs so residents could have access to and be able to afford prescription drugs. Last summer, Newsom announced that California would start by making its own generic insulin, a plan known as the CalRx Biosimilar Insulin Initiative.

The initiative “will lay the groundwork for future drug projects,” as the state expects to continue producing other high-cost prescription drugs. Rather than charging prices for profit, the insulin prices will be close to the actual cost of making and distributing the product, and “they will continue to look for efficiencies that will allow further price reductions,” according to the website.

According to national data, one in four people who rely on insulin has to ration it because they can’t afford it. People with diabetes are expected to save between $2,000 and $4,000 annually on insulin under the CalRx initiative.

State officials hope that increased options in the pharmaceutical market will lower costs for people taking other types of insulins as well, not just for this specific generic drug.

In his announcement, Newsom said, “People should not be forced to go into debt to get life saving prescriptions. Through CalRx, Californians will have access to some of the most inexpensive insulin available, helping them save thousands each year.”

Earlier this month, the three largest insulin producers—Eli Lilly, Novo Nordisk and Sanofi—announced their plans to cut insulin prices. But according to Figueroa, the State of California believes these discounts don’t go quite far enough to address the systemic issues of insulin pricing.

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“Although other manufacturers have announced recent drops in their list prices, their prices are still above the actual cost to make insulin,” said Figueroa. “It is important to us that the low insulin prices are sustained. If the other insulin manufacturers want to further drop the cost of their insulins to try and undercut CalRx, we see that as a ‘win’ for consumers.”

California is investing $50 million into developing these insulins and an additional $50 million will be used to support the construction of a manufacturing facility where the drug will be made.

Pending approval from the US Food and Drug Administration, the contract announced is expected to deliver insulin to Californians starting in 2024. CalRx insulin products are expected to be available in pharmacies throughout California. The CalRx program will be available to all California residents, without eligibility or insurance requirements.

“CalRx has put ‘big pharma’ on notice that huge profits, at the expense of consumers, for generic or biosimilar medications is unacceptable,” Figueroa said. “We anticipate this will be a readable model for other drugs that fall under the CalRx brand and deliver the low, transparent pricing consumers expect and should demand from the pharmaceutical market.”

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