Accord BioPharma's IMULDOSA® Secures Preferred Status with Cigna Healthcare Plans

In a significant development for Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, it has been announced that IMULDOSA® (ustekinumab-srlf) will now be included as a preferred option under Cigna Healthcare's commercial insurance plans. This change, effective from April 15, 2026, is expected to broaden the access of patients to necessary therapies for serious health issues, including moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis.

IMULDOSA® is a biosimilar to the well-known drug STELARA® (ustekinumab), which has shown considerable efficacy in treating complex autoimmune conditions. The approval for IMULDOSA® was granted by the FDA in October 2024, and it aims to provide a more affordable alternative without compromising the quality of care.

Chrys Kokino, the President of Accord North America, expressed that this coverage decision marks a pivotal step in the company's aspiration to become a leader in the biosimilar market in the U.S. Kokino stated, "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." This sentiment is echoed by the ever-growing need for accessible and affordable healthcare solutions in the current landscape.

Benefits of Preferred Status

The preferred formulary status granted by Cigna Healthcare facilitates a smoother process for patients and healthcare providers to access IMULDOSA. Specifically, from April 15, 2026, patients will benefit from:

- IMULDOSA prefilled syringes: These will be preferred on all Cigna Healthcare commercial pharmacy benefit drug lists.
- IMULDOSA vials: These will be preferred under the Cigna Healthcare commercial medical benefit.

However, it is advised for patients to confirm individual plan benefits with their plan administrator or benefits manager to ensure coverage specifics.

Aside from Cigna, IMULDOSA® is also featured on Express Scripts' largest commercial formularies, such as the National Preferred Formulary, commencing from September 5, 2025. This broad coverage is set to enhance the reach of IMULDOSA®, making it a more accessible option for patients in need.

Safety Information

While IMULDOSA has shown promising results, it's important for patients to be informed about its associated risks. The drug may raise the likelihood of infections and possibly reactivate latent infections. Serious bacterial, mycobacterial, fungal, and viral infections have been noted among patients utilizing ustekinumab products, which necessitates careful monitoring following treatment initiation.

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have also been reported. It is crucial that any significant reactions result in immediate discontinuation of the medication and appropriate medical intervention.

Before starting treatment with IMULDOSA, patients should be screened for tuberculosis and it's imperative that the drug not be administered to those with active tuberculosis infections. The risks associated with malignancies were also noted, as ustekinumab products can suppress immune responses. This should be considered, particularly in patients with a history of cancer.

Looking Forward

Accord BioPharma is driven to improve patient outcomes through their commitment to affordable therapeutic options. By striving to launch a total of 20 biosimilars by 2030, Accord emphasizes the necessity of making high-quality treatments accessible to a broader patient demographic. The goal is to position the company as a key player in the biosimilar field, significantly impacting both healthcare costs and patient quality of life.

In conclusion, the inclusion of IMULDOSA® in Cigna Healthcare's formularies highlights a major stride towards improving patient access to necessary treatments for serious health conditions. As the landscape of healthcare continues to evolve with these advancements in biosimilars, it is essential that both providers and patients remain informed about their options and the safety considerations that come with them.