Infliximab

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.

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 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.

FDA approves Celltrion's 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.

The Global Gastrointestinal Diseases Therapeutics Market is projected to grow by USD 18.5 billion from 2024-2028, driven by increasing disease incidence and nutritional therapies. Key players include Abbott Laboratories, AbbVie Inc., AstraZeneca Plc, and others. High treatment costs pose a challenge.

A retrospective study of a mandatory nonmedical switch from infliximab to biosimilars CT-P13 or SB2 in IBD patients found no significant differences in treatment persistence, loss of response, or adverse events 1 year post-switch. Over 90% of patients in both groups remained on infliximab treatment at 12 months, with similar discontinuation rates. The study supports existing data on biosimilar switching and reassures healthcare providers about its safety and efficacy.

The EC approved Celltrion's ustekinumab biosimilar, SteQeyma, for chronic inflammatory diseases. Celltrion expanded Zymfentra access through Cigna and Express Scripts. The AAM held a policy briefing on biosimilar adoption barriers, focusing on patent issues.

A study of biosimilar infliximab-dyyb (CT-P13) in RA found stable disease activity in patients switching from the reference product or another infliximab biosimilar, and improvement in those switching from non-infliximab biologics or tsDMARDs. 68% of patients remained on CT-P13 at 6 months, with 32.9% achieving low disease activity. The study suggests real-world outcomes are comparable to clinical trial efficacy.