CivicaScript, a nonprofit pharmaceutical company focused on affordable generic medicines, announced it will distribute the biosimilar ustekinumab-aauz beginning January 1, 2026, marking the company's entry into the biosimilar market with a treatment for multiple chronic inflammatory conditions.
The biosimilar targets patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. Ustekinumab-aauz is also indicated for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis and active psoriatic arthritis.
Mechanism and Manufacturing Partnership
Ustekinumab-aauz is a human monoclonal antibody that targets cytokines interleukin-12 and interleukin-23, which play important roles in inflammatory and immune responses. The biosimilar is produced by Fresenius Kabi and is interchangeable with the reference product Stelara (ustekinumab) injection for subcutaneous or intravenous use.
CivicaScript will serve as the exclusive distributor of the unbranded ustekinumab-aauz, offering it in prefilled syringes in two different strengths to accommodate varying patient needs.
Transparent Pricing Structure
The company will implement a transparent pricing model with Wholesale Acquisition Prices (WAC) set at $985 for a 12-week supply of 90mg and $575 for a 12-week supply of 45mg. These prices will be available to CivicaScript's members and partners, including health plans and pharmacy benefit managers.
"The launch of ustekinumab-aauz is a major step forward in our mission to make essential medicines more affordable and accessible to all," said CivicaScript President Brent J. Eberle. "We're proud to offer a biosimilar that leverages our transparent business model to help reduce the financial burden on patients and the healthcare system."
Strategic Portfolio Expansion
This biosimilar launch represents a significant expansion for CivicaScript, building on the steady growth of its specialty generic product portfolio. The company has already launched four products in 2025, demonstrating accelerated growth in its therapeutic offerings.
Eberle indicated this represents just the beginning of the company's biosimilar strategy, stating, "We expect this to be the first of several biosimilars we add to our portfolio over the next few years."
Safety Profile and Contraindications
Ustekinumab-aauz is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in the biosimilar formulation. Healthcare providers should refer to the prescribing information for complete safety and dosing details.
The biosimilar's approval for multiple inflammatory conditions provides treatment options for both adult and pediatric populations, with specific indications for patients who are candidates for phototherapy or systemic therapy in psoriasis cases.
