Accord BioPharma's IMULDOSA® Receives Preferred Status in National Formularies

Introduction

Accord BioPharma Inc., a division of Intas Pharmaceuticals, has recently announced significant progress in its immunology franchise. As of September 5, 2025, its biosimilar product, IMULDOSA® (ustekinumab-srlf), has been included in the national formularies of Express Scripts, one of the United States' largest pharmacy benefit managers. This milestone is pivotal in enhancing patient access to essential therapies that target a variety of chronic inflammatory conditions.

Background

IMULDOSA® is designed as a biosimilar to the well-known drug STELARA® (ustekinumab), receiving its FDA approval for the same indications. Both therapies are utilized to treat conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Notably, IMULDOSA® provides no clinically significant differences compared to its reference product, affirming its therapeutic equivalence.

The drug is available in convenient formats - a pre-filled syringe targeting easier administration for patients and a single-dose vial for intravenous infusion. This versatility caters to diverse patient needs and preferences.

Expansion of Patient Access

The inclusion of IMULDOSA® in Express Scripts’ formularies is an important stride towards broadening access to effective treatments. Chrys Kokino, President of Accord North America, emphasized their commitment to ensuring that cost does not hinder patients from receiving potentially life-altering therapies. By securing a place on one of the largest pharmacy benefit managers' formularies, Accord BioPharma reaffirms its mission to facilitate access to biologic medications.

Paul Purdy, VP of Market Access at Accord BioPharma, highlighted that this partnership validates their ongoing efforts to increase the availability of affordable biologic solutions for patients managing chronic immune-mediated inflammatory disorders. The goal is clear: to work synergistically with other major pharmacy benefit managers to ensure that IMULDOSA® reaches patients nationwide.

Important Safety Information

While the benefits of IMULDOSA® are significant for patients suffering from chronic inflammatory conditions, it is also crucial to understand its safety profile. Certain contraindications exist, such as hypersensitivity to ustekinumab products. Patients using IMULDOSA® may experience an increased risk of various infections, including serious and opportunistic infections. Therefore, careful consideration of patients' health status and history of infections is essential prior to commencing therapy.

Moreover, due to its immunosuppressive effects, there is an elevated risk of malignancies with ustekinumab-based treatments. This necessitates vigilance in monitoring patients, particularly those with pre-existing risk factors for skin cancer or other malignancies.

Furthermore, monitoring for signs of Posterior Reversible Encephalopathy Syndrome (PRES) is advised, as there have been reports tying its occurrence to ustekinumab. Patients undergoing treatment should be educated regarding these potential adverse effects and the importance of promptly reporting any unusual symptoms.

Conclusion

Accord BioPharma's expansion into major formularies through IMULDOSA® is not only a step forward for the company but also a substantial win for patients in need of effective therapy for chronic conditions. With a commitment to affordability and access, Accord BioPharma is paving the way for a more inclusive healthcare landscape. As they continue to navigate partnerships with key pharmacy benefit managers, the emphasis remains on patient-centric solutions that improve lives. For further details, the comprehensive prescribing information of IMULDOSA® can be accessed on their official site or through direct inquiries to Accord BioPharma, as patient safety and education remain paramount.

For more information, please visit imuldosa.com.