Imuldosa Prefilled Syringes Now Available at 92% Discount From Reference Product, Stelara

Accord BioPharma announced today the commercial launch of discounted, prefilled syringes of Imuldosa (ustekinumab-srlf), a Stelara (ustekinumab) biosimilar, according to a news release.

Imuldosa is supplied as a single-dose prefilled syringe for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths or as a single-dose vial for intravenous infusion in 130 mg/26 mL. The prefilled syringes of Imuldosa are priced at a 92% discount from Stelara, making it the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars. The vial formulations are offered at a 33% discount. Accord BioPharma will also launch a $0 co-pay Imuldosa program for eligible patients, according to the news release.

Biosimilars are biologic medicines that are highly similar to an already approved biologic and have no clinically meaningful differences in safety, purity, or potency. Their introduction has been a cornerstone of U.S. efforts to increase competition in the biologics market, lower costs and expand access to critical therapies. For patients living with chronic immune-mediated conditions, lower-cost options can mean the difference between consistent treatment and interruptions in care due to affordability issues.

Stelara was originally approved by the FDA in 2009 for adults with moderate to severe plaque psoriasis. It currently has eight biosimilars across multiple indications for both adult and pediatric patients, including moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.

Imuldosa was approved by the FDA in October 2024 as the fifth Stelara biosimilar.

Immune-mediated inflammatory conditions affect approximately 50 million Americans. These diseases are often lifelong, requiring ongoing management to control symptoms and prevent serious complications. Without treatment, patients can face disability, increased hospitalization, and reduced quality of life. Yet cost remains a significant barrier.

For example, the list price of Stelara is $25,497.12 every eight weeks for the 90 mg dose. While some privately insured patients can pay as little as $5 with Stelara assistance programs, this does not apply to patients using Medicare, Medicaid or other government-funded programs to pay for their medication. For many patients, particularly older adults or those with limited income, the high cost of biologic therapies makes access to treatment difficult. Biosimilars like Imuldosa aim to address this gap.

Accord BioPharma is the specialty division of Intas Pharmaceuticals, which focuses on the development of oncology and immunology therapies. This is Accord BioPharma’s third in-market biosimilar.

"At Accord BioPharma, we believe that cost shouldn't be a barrier to accessing proven, life-changing therapies," Chrys Kokino, Accord U.S. President, said in the news release. "The launch of Imuldosa represents our commitment to going beyond simply providing biosimilar alternatives to delivering comprehensive solutions that can make a meaningful difference in patients' lives.”

Imuldosa is a human interleukin-12 and -23 antagonist with no clinically meaningful differences from Stelara, according to the prescribing information. Because Imuldosa is an immunosuppressant, it may increase the risk of certain infections such as diverticulitis, pneumonia and listeria meningitis.

The most common adverse reactions of ustekinumab products per indication are as follows:

• Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache and fatigue
• Crohn's Disease, induction (≥3%): vomiting
• Crohn's Disease, maintenance (≥3%): nasopharyngitis, injection site erythema and vulvovaginal candidiasis/mycotic infection
• Ulcerative colitis, induction (≥3%): nasopharyngitis
• Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain and influenza