CivicaScript Launches Low-Cost Insulin Biosimilar and Ustekinumab Alternative in US Market
Key Insights
CivicaScript (search) has launched insulin glargine-yfgn, an interchangeable biosimilar to Lantus, priced at $45 per box of five pens to pharmacies with a maximum consumer price of $55.
The nonprofit also introduced ustekinumab-aauz, a biosimilar to Stelara for inflammatory conditions, with 12-week supplies priced at $985 for 90mg and $575 for 45mg.
Both products represent significant cost reductions compared to current market prices and are part of CivicaScript (search)'s transparent pricing model to improve medication affordability.
CivicaScript (search), a nonprofit generic drug company, has launched two significant biosimilar products that promise to substantially reduce medication costs for patients with diabetes and chronic inflammatory conditions. The company announced the availability of insulin glargine-yfgn and ustekinumab-aauz, marking a major expansion of its low-cost treatment portfolio.
Affordable Insulin Alternative Enters Market
The insulin glargine-yfgn product, which is interchangeable with Lantus (insulin glargine), represents what CivicaScript (search) claims is "the lowest list price in the current long-acting insulin market." The biosimilar is available in prefilled pens for $45 per box of five pens to pharmacies, with a maximum recommended consumer price of $55.
"This stable, transparent price contrasts with copay assistance programs offered by other manufacturers, which require patients to register for programs that can change at any time," the company stated. The cost to consumers may be even lower than $55, depending on individual insurance plans.
The insulin product is indicated to improve glycemic control in both adult and pediatric patients with diabetes mellitus (search). CivicaScript (search) is distributing the insulin nationwide under its own label, while California pharmacies will use the CalRx brand through a partnership with the state's CalRx program.
Inflammatory Disease Treatment Option
Ustekinumab-aauz, a biosimilar to Stelara (ustekinumab), is indicated for treating chronic inflammatory conditions including plaque psoriasis (search), psoriatic arthritis (search), Crohn's disease (search), and ulcerative colitis (search). The IL-12/23 (search) antagonist is available in pre-filled syringes for subcutaneous injection in two strengths.
The Wholesale Acquisition Cost for a 12-week supply is $985 for the 90mg strength and $575 for the 45mg strength. The biosimilar is also indicated for pediatric patients six years of age and older with moderate to severe plaque psoriasis (search) who are candidates for phototherapy or systemic therapy, and for pediatric patients six years of age and older with active psoriatic arthritis (search).
Manufacturing Partnership and Distribution Strategy
The insulin launch is the result of a manufacturing and supply partnership with Biocon Biologics (search) that was announced in October. CivicaScript (search) President Brent J. Eberle emphasized the company's mission, stating, "Our growing portfolio shows that putting patients first isn't just the right thing to do – it's a proven path to delivering affordable generics and biosimilars."
Both therapies are offered under CivicaScript (search)'s transparent pricing model for pharmacies, health plans, and pharmacy benefit managers. The nonprofit operates as a unit of Civica Rx, which was founded by U.S. health systems specifically to address generic drug shortages and pricing concerns.
Safety Considerations and Prescribing Information
The insulin product comes with specific administration guidelines, including warnings not to dilute or mix insulin glargine-yfgn with any other insulin or solution, as this may cause the solution to become cloudy and alter the onset of action in an unpredictable manner. The product should not be administered via an insulin pump or intravenously due to hypoglycemia risk.
Ustekinumab-aauz is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in the formulation. Healthcare providers and patients are encouraged to report negative side effects to the FDA through MedWatch or by calling 1-800-FDA-1088.