South Korean biopharmaceutical company Celltrion announced on Wednesday that it has launched STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), in the United States.

This follows US Food and Drug Administration (FDA) approval in December 2024.

STEQEYMA is approved for the same indications as STELARA, providing consistency in treatment for patients and healthcare providers.

STEQEYMA is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and paediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients. It is available in both subcutaneous injection and intravenous infusion. It will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of STELARA.

The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a Phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. Clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy.