Accord BioPharma has announced the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab), marking a significant milestone in expanding patient access to targeted biologic therapy for immune-mediated inflammatory conditions. The prefilled syringes are priced at the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars, offering a 92% discount from STELARA.
Addressing Critical Patient Needs
Millions of Americans suffer from chronic, immune-mediated inflammatory conditions, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. These conditions are often incredibly painful and debilitating, impacting patients' quality of life, emotional well-being, and self-image. While biologics such as STELARA have had a transformative impact on many patients' lives, they often come with high costs that can prohibit access.
IMULDOSA has been proven to be highly similar to STELARA with no clinically meaningful differences and is FDA-approved for the same indications as the reference product. The biosimilar is indicated for adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. It is also approved for pediatric patients 6 years and older with moderate to severe plaque psoriasis and active psoriatic arthritis.
Maximizing Patient Access Through Pricing Strategy
Accord BioPharma has strategically priced IMULDOSA to maximize patient access across all formulations. The prefilled syringes, which represent the majority of presentations in the ustekinumab market, feature the lowest WAC price among branded ustekinumab biosimilars at a 92% discount from STELARA, while the vial formulation offers a 33% discount.
The company is launching IMULDOSA with a $0 co-pay program for eligible patients, ensuring that more people living with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis can receive proven targeted biologic therapy.
"At Accord BioPharma, we believe that cost shouldn't be a barrier to accessing proven, life-changing therapies," said Chrys Kokino, Accord U.S. President. "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."
Building the Immunology Franchise
This IMULDOSA launch establishes the foundation for Accord BioPharma's immunology franchise, demonstrating the company's commitment to addressing critical needs in immune-mediated inflammatory conditions. The biosimilar represents Accord BioPharma's third in-market biosimilar, furthering the company's mission to expand patient access to potentially life-changing biologic therapies.
As Accord BioPharma prepared for the commercial launch, the company solicited feedback from their patient advisory board on the development of patient support materials, incorporating valuable input from these co-creation sessions.
Expanding Portfolio and Pipeline
Accord BioPharma's portfolio has experienced significant growth within the past year. In addition to launching IMULDOSA, the company recently assumed U.S. operations for the full UDENYCA® (pegfilgrastim-cbqv) franchise, including the UDENYCA pre-filled syringe, autoinjector, and UDENYCA ONBODY®. The company also markets HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), and CAMCEVI® (leuprolide) 42 mg injectable emulsion.
Intas Pharmaceuticals has an exclusive agreement with Bio-Thera Solutions to enable Accord BioPharma to bring Bio-Thera's golimumab candidate BAT2506 – a biosimilar to Simponi® (golimumab) – to the U.S. market, further expanding the pipeline. Accord BioPharma has also submitted Biologics License Applications to the FDA for biosimilar versions of several other biologics.
Corporate Leadership and Vision
"The launch of IMULDOSA in the United States represents our unwavering commitment to making high-quality, more cost-effective biologic therapies more accessible within immunology's critical therapeutic areas," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "Through Accord BioPharma, we are establishing ourselves in the U.S. as a trusted, reliable ally highly attuned to the needs of our stakeholders and dedicated to transforming patient care."
Accord BioPharma believes deeply in the power of biosimilars to reshape the future of treatment. With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape across several priority therapeutic areas by introducing biosimilars to the U.S. market.
IMULDOSA is supplied as single-dose prefilled syringes 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 (5 mg/mL) strength.
