FDA approves Celltrion's Stelara biosimilar
The Food and Drug Administration has approved Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson's 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 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," said Thomas Nusbickel, chief commercial officer at Celltrion USA.
Nusbickel added, "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."
[Read more: FDA gives Biocon Biologics approval for Stelara biosimilar]
"Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients," said Dr. Mark G. Lebwohl, of the Icahn School of Medicine at Mount Sinai, New York.
Lebwohl added, "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 U.S. adult population."
[Read more; Evernorth to offer Stelara biosimilar at $0 out of pocket for patients early next year]
Ustekinumab is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines that play an important role in inflammatory and immune responses. Celltrion 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.
[Read more: Fresenius Kabi, Formycon receive FDA nod for Stelara biosimilar]