Celltrion Announces U.S. Launch of STEQEYMA? (Ustekinumab-stba), a Biosimilar to STELARA?

Celltrion has officially launched STEQEYMA? (ustekinumab-stba) in the United States following approval by the U.S. Food and Drug Administration (FDA) in December 2024. As a biosimilar to STELARA? (ustekinumab), STEQEYMA offers patients and healthcare providers a consistent and effective treatment option for several chronic inflammatory diseases.

Indications and Availability

STEQEYMA is approved for the same indications as STELARA, including:

Plaque Psoriasis (PsO)

Psoriatic Arthritis (PsA) in adult and pediatric patients

Crohn's Disease (CD) and Ulcerative Colitis (UC) in adult patients

STEQEYMA is available in both subcutaneous injection and intravenous infusion formulations, providing flexibility for patients based on their treatment needs.

Supporting Patient Access

As part of its commitment to improving access to essential therapies, STEQEYMA will be priced at an 85% discount to the current list price of STELARA. This price reduction aims to make STEQEYMA a more affordable option, especially for patients managing chronic inflammatory conditions.

Clinical Data

The FDA approval of STEQEYMA was supported by extensive evidence, including results from a Phase III study evaluating its use in adults with moderate to severe plaque psoriasis. The clinical data demonstrated that STEQEYMA and STELARA are highly similar in terms of safety and efficacy, with no clinically meaningful differences observed. This evidence provides confidence that STEQEYMA will be a reliable treatment option for patients.

Expert Insights

Mark G. Lebwohl, MD, from the Icahn School of Medicine at Mount Sinai in New York, commented:

"Chronic inflammatory diseases such as plaque psoriasis and psoriatic arthritis place significant burden on patients. Biosimilars increase access to essential therapies, while maintaining the same high standards as the reference product. The availability of STEQEYMA provides patients and healthcare providers a cost-effective alternative to manage chronic inflammatory diseases."

Expanding Access to High-Quality Treatments

Celltrion’s Chief Commercial Officer, Thomas Nusbickel, stated:

"The introduction of STEQEYMA in the U.S. represents a significant step in our efforts to expand patient access to high-quality biologic treatments. We are now expanding our immunology portfolio to include IL-12/23 inhibitors, offering more options for patients with immune-mediated diseases. To further enhance accessibility, we are actively collaborating with pharmacy benefit managers to secure broader formulary coverage for STEQEYMA."

Patient Support Programs

In line with its commitment to patient care, Celltrion provides comprehensive support for patients using STEQEYMA. Through programs like Celltrion CONNECT? (Patient Support Program) and Celltrion CARES? (Co-pay Assistance Program), patients can access a range of resources, including benefits verification, prior authorization assistance, and financial support.

Eligible patients with private or commercial insurance may pay as little as $0 out of pocket per dose. Additionally, uninsured patients may be eligible for the Celltrion CONNECT? Patient Assistance Program (PAP). Nurses are also available to assist with injection support and answer any questions.