Civica Initiates Project to Manufacture, Distribute Insulin Biosimilars for Uninsured Patients

Civica Rx announced a collaboration project that will allow the company to manufacture and distribute 3 insulin biosimilars that, once approved, will increase access to affordable insulins for people with diabetes.

The Lehi, Utah-based company said that it hopes to make the biosimilars available by early 2024, contingent on FDA approval.

Civica said in a statement that the availability of affordable insulins will help people with diabetes who have had to choose between life-sustaining medications and other necessities for life. This especially applies to those who are uninsured, underinsured, or often pay out-of-pocket for their medications.

Nearly one-quarter of all insulin users in the United States skip or ration doses to save money because of the high costs associated with insulin products; however, these actions can lead to debilitating and preventable complications. This issue disproportionally impacts low-income patients who are uninsured or underinsured, or are Black, Hispanic, or Indigenous.

“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," said Martin VanTrieste, president and CEO of Civica Rx. "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 diabete."

Through the project, Civica will produce biosimilars for Lantus (insulin glargine), Humalog (insulin lispro), and Novolog (insulin aspart), all of which will be offered in vials and prefilled pens. The company will codevelop and manufacture the products, run the clinical trials, and be responsible for filings the applications needed for FDA approval.

Civica plans to set the prices for patients to be no more than $30 per vial or $55 for a box of 5 pen cartridges, which is significantly lower than the prices that are currently charged to patients without health insurance, including CMS’ payment model that caps insulin co-pays to $35 per 30-day supply.

The company said that it will base the pricing on the cost of development, production, and distribution. Previously, Civica entered into a commercialization agreement with GeneSys Biologics for the biosimilars, meaning that GeneSys will produce them using Civica’s 140,000 square foot manufacturing plant in Virginia and Civica will have the exclusive marketing rights for the United States.

Civica, along with CivicaScript and the Civica Foundation, is collaborating with 25 health systems, including Arnold Ventures, Beyond Type 1, Blue Cross Blue Shield Association, and 12 independent Blue Cross Blue Shield companies:

• Arkansas Blue Cross and Blue Shield
• Blue Cross and Blue Shield of Alabama
• Blue Cross and Blue Shield of Hawaii
• Blue Cross and Blue Shield of Vermont
• Blue Cross of Idaho
• Blue Shield of California
• CareFirst BlueCross BlueShield
• Excellus BlueCross BlueShield
• Florida Blue
• Highmark Blue Cross Blue Shield
• Horizon Blue Cross Blue Shield of New Jersey
• Independence Blue Cross

The other partners include Gary and Mary West Foundation, Glen Tullman Family Foundation, Intermountain Healthcare, JDRF, Kaiser Permanente, Peterson Center on Healthcare, Providence, The Leona M. and Harry B. Helmsley Charitable Trust, Transcarent, and Trinity Health.

“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,” said Dan Liljenquist, board chair of Civica.

In January 2019, Civica Rx added 12 health systems to a similar project at offering generic drugs at an affordable price for patients struggling to pay for medications, which brought their total to 750 hospitals in the United States.