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Celltrion's Crohn's treatment set for February U.S. release

Published: 18 Dec. 2024, 18:08

LEE JAE-LIM
[email protected]

Logo of Celltrion [CELLTRION]

Celltrion’s Steqeyma, a biosimilar that references Johnson & Johnson’s blockbuster monoclonal antibody Stelara, received approval from the U.S. Food and Drug Administration (FDA) to target market release in February, the Korean drugmaker said Wednesday.

Steqeyma can treat plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

The biopharmaceutical firm has received market approval for the biosimilar in major markets such as Korea, Europe and Canada, with the United States being the latest addition.

The global market for ustekinumab, Stelara's active ingredient, was valued at $20.4 billion last year, with the U.S. market alone accounting for 77 percent of that total, according to market tracker IQVIA.

The drugmaker has recently secured approval for other pipeline products such as Omriclone, Steqeyma, Aidengel and Stovoklo-Ocenbelt, aligning with its target initiative to build a portfolio of 11 biosimilars by 2025.

“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 Celltrion USA Chief Commercial Officer Thomas Nusbickel in a statement. “Steqeyma is now the latest biologic in our immunology portfolio, joining Zymfentra. Our portfolio, supported by our fully integrated platform, establishes Celltrion USA as an important player in the U.S. immunology market.”

BY LEE JAE-LIM [[email protected]]