The FDA has approved ustekinumab-stba (Steqeyma; Celltrion) for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis.
The FDA approval was based on the results from a 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 for skin symptoms.
The results that Steqeyma and its reference product, ustekinumab (Stelara; Janssen) are highly similar, and have no clinically meaningful differences in terms of safety and efficacy.
“Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients,” Mark G. Lebwohl, MD, Icahn School of Medicine at Mount Sinai, New York, noted in a prepared statement about the approval. “The approval of a new treatment option is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affect more than 3% of the US adult population.”
Reference
- Celltrion. U.S. FDA approves Celltrion’s Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab). Press release. Published December 18, 2024. Accessed December 18, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-steqeyma-ustekinumab-stba-a-biosimilar-to-stelara-ustekinumab-302334458.html