The U.S. Food and Drug Administration (FDA) has approved STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), 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 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. The 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.
“The approval of STEQEYMA reflects Celltrion’s continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn’s disease, psoriasis, and psoriatic arthritis,” says Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, in a news release. “STEQEYMA is now the latest biologic in our immunology portfolio, joining ZYMFENTRA (infliximab-dyyb). Our portfolio, supported by our fully integrated platform, establishes Celltrion USA as an important player in the U.S. immunology market.”
“Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients,” adds Mark G. Lebwohl, MD, Professor and Systemn Chaior of Dermatology at Icahn School of Medicine at Mount Sinai in New York, NY. “The approval of 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.”
Ustekinumab is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23. Celltrion Inc. had reached a settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson, granting a license entry date for STEQEYMA in the United States in February 2025.
