Accord BioPharma's Ustekinumab Biosimilar IMULDOSA Gains Preferred Status on Cigna Healthcare Formularies
核心洞察
Accord BioPharma (搜索) announced that IMULDOSA (ustekinumab-srlf (搜索)), a biosimilar to STELARA, has achieved preferred formulary status under Cigna Healthcare (搜索) commercial plans effective April 15, 2026.
The biosimilar is approved for treating multiple inflammatory conditions including moderate to severe plaque psoriasis (搜索), active psoriatic arthritis (搜索), and moderately to severely active Crohn's disease (搜索) and ulcerative colitis (搜索) in both adult and pediatric patients.
IMULDOSA prefilled syringes are preferred on pharmacy benefits while vials are preferred on medical benefits, providing streamlined access for patients and healthcare providers.
Accord BioPharma (搜索) announced that its ustekinumab biosimilar IMULDOSA (ustekinumab-srlf (搜索)) has achieved preferred formulary status under Cigna Healthcare (搜索) commercial plans, effective April 15, 2026. The biosimilar, which received FDA approval in October 2024, represents a significant milestone in expanding patient access to affordable biologic therapies for multiple inflammatory conditions.
Formulary Coverage Details
The preferred formulary status provides comprehensive coverage across both pharmacy and medical benefits. IMULDOSA prefilled syringes are now preferred on all Cigna Healthcare (搜索) commercial pharmacy benefit drug lists, while vials are preferred on the commercial medical benefit. This dual coverage approach ensures streamlined access for patients requiring different administration routes.
"This coverage decision represents meaningful progress in our mission to become a leader within the U.S. biosimilar industry," said Chrys Kokino, President of Accord North America. "Every formulary win brings us closer to ensuring cost isn't a barrier for patients to access proven biologic therapies for urgent and critical medical conditions."
Therapeutic Indications and Patient Population
IMULDOSA, a biosimilar to STELARA (ustekinumab), is approved for treating multiple inflammatory conditions in both adult and pediatric populations. For adult patients, the biosimilar is indicated for moderate to severe plaque psoriasis (搜索) in candidates for phototherapy or systemic therapy, active psoriatic arthritis (搜索), moderately to severely active Crohn's disease (搜索), and moderately to severely active ulcerative colitis (搜索).
The pediatric indications cover patients 6 years and older with moderate to severe plaque psoriasis (搜索) who are candidates for phototherapy or systemic therapy, as well as active psoriatic arthritis (搜索). The drug functions as a human interleukin-12 (搜索) and -23 antagonist, targeting key inflammatory pathways involved in these autoimmune conditions.
Formulation and Administration
IMULDOSA is available in multiple formulations to accommodate different clinical needs. The drug is supplied as single-dose prefilled syringes for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths, as well as single-dose vials for intravenous infusion in 130 mg/26 mL (5 mg/mL) strength.
Safety Profile and Monitoring Requirements
The biosimilar carries important safety considerations consistent with ustekinumab products. Healthcare providers must evaluate patients for tuberculosis infection prior to treatment initiation and avoid administering IMULDOSA to patients with active tuberculosis. The drug may increase infection risk and reactivation of latent infections, with serious bacterial, mycobacterial, fungal, and viral infections observed in clinical trials.
Serious infections reported across different indications included diverticulitis, cellulitis, pneumonia, and sepsis in plaque psoriasis (搜索) patients; cholecystitis in psoriatic arthritis (搜索) patients; and anal abscess, gastroenteritis, and listeria meningitis in Crohn's disease (搜索) patients. Healthcare providers should discontinue IMULDOSA for serious infections until adequately treated.
The most common adverse reactions vary by indication, with nasopharyngitis, upper respiratory tract infection, headache, and fatigue being most frequent in psoriasis and psoriatic arthritis (搜索) patients. Crohn's disease (搜索) patients most commonly experienced vomiting during induction and nasopharyngitis during maintenance therapy.
Market Access Expansion
Beyond Cigna Healthcare (搜索), IMULDOSA is included on Express Scripts (搜索)' largest commercial formularies, including the National Preferred Formulary, effective September 5, 2025. This expanded formulary access supports Accord BioPharma (搜索)'s broader strategy to increase biosimilar adoption and reduce healthcare costs.
Company Strategic Goals
Accord BioPharma (搜索), the U.S. specialty division of Intas Pharmaceuticals, Ltd., focuses on developing oncology and immunology therapies with an emphasis on affordability and accessibility. The company has set an ambitious goal to launch 20 biosimilars by 2030, positioning itself to offer one of the deepest biosimilar portfolios in the industry.
The IMULDOSA formulary inclusion aligns with the company's mission to provide more affordable, accessible, patient-centric therapies while delivering savings to the U.S. healthcare system. Patients and providers should confirm individual plan benefits with their plan administrator or benefits manager to understand specific coverage details.