FDA Approves Celltrion’s Steqeyma to Treat Autoimmune Diseases

Celltrion has received U.S. Food and Drug Administration (FDA) approval for its autoimmune disease treatment drug Steqeyma, a biosimilar of Johnson & Johnson’s Stelara (ustekinumab). Product approval is for the full label indications held by the original drug, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Ustekinumab products are IL-12 and IL-23 antagonists used for the treatment of plaque psoriasis, psoriatic arthritis and IBD, which is an umbrella term for Crohn’s disease and ulcerative colitis. The originator product, Stelara, is available in intravenous and subcutaneous formulations. It’s also one of the first 10 products selected by the Centers for Medicare and Medicaid as part of drug price negotiations as part of the Inflation Reduction Act.

Approval is based on a global Phase III clinical trial results in adults with moderate to severe plaque psoriasis. The study’s primary end point measured changes in the Psoriasis Area and Severity Index for skin symptoms. Clinical findings confirmed that Steqeyma and its reference product are highly similar to each other with no clinically meaningful differences in safety or 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,” said Thomas Nusbickel, chief commercial officer at Celltrion USA. “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.”

Celltrion officially launched Steqeyma in the U.S. market in February. Subcutaneous injections of Steqeyma will come in two strengths: 45 mg/0.5 mL and 90 mg/1 mL, each provided in a single-dose prefilled syringe. The intravenous infusion is supplied as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.

The approval represents the seventh biosimilar approval for a Stelara competitor. Steqeyma follows Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub) and Yesintek (ustekinumab-kfce), the last of which was approved at the beginning of December 2024.