"Celltrion has announced the availability of STEQEYMA® (ustekinumab-stba) in the United States, following its approval by the U.S. Food and Drug Administration (FDA) in December 2024.
Chronic inflammatory diseases such as psoriasis and psoriatic arthritis pose significant challenges for patients. Biosimilars offer an alternative treatment option that maintains the same safety and efficacy standards as the reference product. STEQEYMA is launched at a wholesale acquisition cost (WAC) set at an 85% discount compared to STELARA, aiming to improve patient access to high-quality biologic therapies.
Previously known as CT-P43, STEQEYMA® is a human IL-12 and IL-23 antagonist used for the treatment of various immune-mediated conditions. It is approved for all the indications covered by the reference product STELARA®, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC) in adults, as well as PsO and PsA in children aged six years and older.
STEQEYMA is available in two formulations: subcutaneous injection and intravenous infusion. The subcutaneous injection is provided in 45mg/0.5 mL and 90mg/1 mL prefilled syringes, while the intravenous infusion is supplied as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.
STEQEYMA is a biosimilar to STELARA® (ustekinumab) and is approved for the same medical conditions, ensuring consistency in treatment for patients and healthcare professionals.
The biosimilar is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in both adults and children, as well as Crohn’s disease (CD) and ulcerative colitis (UC) in adults. It is available in subcutaneous and intravenous formulations.
The FDA's approval was based on comprehensive data, including results from a Phase III clinical trial involving adults with moderate to severe plaque psoriasis.
With the introduction of STEQEYMA, Celltrion has expanded its immunology portfolio beyond TNF-alpha inhibitors to include IL-12/23 inhibitors, providing additional treatment options for immune-mediated diseases.
Celltrion has a strong presence in the biosimilar market, with nine FDA-approved biosimilars. STEQEYMA has also secured approval in other major global markets, including the European Union, Canada, and Australia.