Celltrion Inc

The FDA approved Steqeyma (ustekinumab-stba), the seventh biosimilar to Stelara, for inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Steqeyma demonstrated comparable efficacy and safety to Stelara in trials, with a PASI score improvement of 77.93% vs. 75.89%. It will be available as a subcutaneous injection or intravenous infusion, expected on the market in February 2025.

EMA's CHMP gave positive opinions for Celltrion's three biosimilar candidates, including Eydenzelt (biosimilar aflibercept), Stoboclo and Osenvelt (biosimilar denosumab), and Avtozma (biosimilar tocilizumab). Eydenzelt is recommended for treating multiple retinal disorders and met equivalence criteria in a Phase III study. The European Commission will decide on marketing authorization.

FDA approved Celltrion's Stelara biosimilar Steqeyma for psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Steqeyma, a fully human monoclonal antibody, showed no clinical or safety differences from ustekinumab in a phase 3 study. It will be available in subcutaneous and intravenous formulations in 2025. Other Stelara biosimilars have also been approved.

The FDA approved Celltrion’s Steqeyma, a biosimilar to Stelara, for treating plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Steqeyma, an IL-12 and IL-23 antagonist, is available in SC and IV formulations. The approval reflects Celltrion’s commitment to expanding treatment options for chronic inflammatory diseases affecting millions in the US.

The FDA approved Celltrion's Steqeyma, a biosimilar to Stelara, for psoriatic conditions and IBD. Steqeyma is the seventh biosimilar for Stelara, joining Celltrion's immunology portfolio. It is available in subcutaneous and intravenous forms and is supported by phase III study data showing similarity to Stelara in safety and efficacy.

Ustekinumab-stba (Steqeyma; Celltrion) received FDA approval for treating plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis in adults and pediatric patients. It selectively inhibits IL-12 and IL-23, available as subcutaneous injection or intravenous infusion, launching in Feb 2025.

The FDA approved Celltrion's Steqeyma as the seventh Stelara biosimilar for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, with a launch expected in February 2025.

The FDA approved Celltrion's CT-P43/ustekinumab-stba (Steqeyma), an ustekinumab biosimilar, for plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Based on phase III evidence, Steqeyma demonstrated high similarity to ustekinumab in efficacy and safety, with expected launch in February 2025.

Celltrion announced FDA approval of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA®, for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults and pediatric patients. STEQEYMA is expected to be marketed in the U.S. in February 2025, expanding Celltrion’s immunology portfolio.