Cigna Favors IMULDOSA, Boosting Access to Cheaper Autoimmune Drug

RALEIGH, NC – April 20, 2026 – In a move poised to reshape access to critical autoimmune treatments, Cigna Healthcare has designated IMULDOSA®, a biosimilar drug from Accord BioPharma, as a preferred therapy on its commercial health plans. The decision, effective April 15, 2026, signals a significant shift in the multi-billion-dollar market for immunology drugs, promising enhanced affordability for millions of Americans battling chronic conditions.

IMULDOSA® (ustekinumab-srlf) is a biosimilar to Johnson & Johnson’s blockbuster drug STELARA® (ustekinumab). Approved by the FDA in October 2024, it treats a range of debilitating inflammatory diseases, including moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. By placing IMULDOSA on its preferred formulary, Cigna is making a lower-cost, clinically equivalent option more accessible to its members, a decision that underscores a powerful trend toward cost-containment across the U.S. healthcare system.

A New Era of Affordability for Chronic Disease Patients

For years, patients requiring biologic therapies have faced a significant financial burden. The reference product, STELARA®, has been a prime example, with a list price that could exceed $25,000 for a single dose and annual costs climbing into the hundreds of thousands of dollars for patients without robust insurance or assistance. This high cost has often been a formidable barrier to care, forcing difficult choices between financial stability and consistent treatment.

The introduction and preferred coverage of biosimilars like IMULDOSA® are set to dramatically alter this landscape. Biosimilars enter the market at a substantial discount to their originator counterparts, with some ustekinumab biosimilars launching with list prices 80% to 90% lower than STELARA®'s. Cigna’s decision to prefer IMULDOSA® means that patients on its commercial plans will likely see significantly lower out-of-pocket costs through reduced co-pays and co-insurance.

This improved affordability is crucial for treatment adherence. Patient advocacy groups for Crohn's disease, psoriasis, and other autoimmune conditions have long highlighted cost as a major factor in patients skipping doses or abandoning treatment altogether, leading to poorer health outcomes. By reducing this financial toxicity, the availability of preferred biosimilars can empower patients to maintain their prescribed therapy, leading to better disease management and an improved quality of life.

Shifting Tides in the Biologic Drug Market

The move by Cigna is a key event in the ongoing disruption of the biologic drug market. STELARA® was once a titan for its manufacturer, Johnson & Johnson, generating over $10 billion in global sales in 2023. However, with the expiration of its primary U.S. patent in late 2023, the drug has entered a period of steep decline, a phenomenon known as the "patent cliff."

J&J successfully negotiated legal settlements to delay the U.S. launch of biosimilars until early 2025, but the floodgates have since opened. The market is now experiencing a "biosimilar gold rush," with at least seven different ustekinumab biosimilars commercially available as of mid-2025. This influx of competition has rapidly eroded STELARA®'s market share, with its sales plummeting by an estimated 60% in the first quarter of 2026 compared to the prior year.

For Accord BioPharma, securing preferred status with a major national insurer like Cigna is a monumental strategic victory. In a crowded field of new competitors, formulary placement is the ultimate prize, guaranteeing access to a large patient population and providing a crucial competitive edge. This win is further bolstered by IMULDOSA's inclusion on the National Preferred Formulary of Express Scripts, Cigna’s pharmacy benefit manager (PBM), since September 2025, solidifying its position in the market.

The Insurer's Playbook: Driving Down Healthcare Costs

Cigna's decision is not an isolated event but rather a clear reflection of a broader industry strategy. Insurers and PBMs are the primary gatekeepers of drug access, and they are increasingly leveraging their power to drive down costs by favoring biosimilars. The primary criterion for these decisions is the drug’s net cost to the health plan, which is determined by a combination of list price, rebates, and other contractual terms.

Interestingly, Accord BioPharma’s IMULDOSA® achieved this preferred status without an "interchangeable" designation from the FDA—a status that allows a pharmacist to substitute a biosimilar for its reference product without consulting the prescriber. While interchangeability is an advantage, Cigna’s preference for IMULDOSA® demonstrates that aggressive pricing and effective contracting can be even more powerful drivers of formulary placement.

This strategy is having a profound impact. Surveys of payers and PBMs indicate that a majority are likely to remove the originator drug, STELARA®, from their formularies entirely by mid-2026, effectively forcing a switch to one of the preferred biosimilar options. By creating this competitive environment, insurers aim to generate billions in savings for the healthcare system, employers, and ultimately, their members.

Accord BioPharma's Bold Bet on Biosimilars

This formulary win is a cornerstone of Accord BioPharma’s ambitious long-term vision. The U.S. specialty division of Intas Pharmaceuticals has set a bold goal of launching 20 biosimilars by 2030, aiming to become a leader in the U.S. biosimilar industry. This strategy is built on the belief that biosimilars are key to increasing patient access and delivering substantial savings to the healthcare system.

"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, in the company's announcement. "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."

The successful launch and market access for IMULDOSA® provides Accord with significant momentum and credibility. It serves as a powerful case study for the company's ability to navigate the complex U.S. payer landscape and provides a valuable blueprint as it prepares to launch other biosimilars in its pipeline, which includes treatments for oncology. This single victory is a critical step in a much larger campaign to reshape the market for high-cost specialty drugs. The complex interplay of intense biosimilar competition, aggressive payer strategies, and federal policies like the Inflation Reduction Act's drug price negotiations are collectively forging a new, more competitive, and potentially more affordable future for specialty medicine in the United States.