Ustekinumab
- Generic Name
- Ustekinumab
- Brand Names
- Stelara, Pyzchiva, Uzpruvo, Wezenla, Steqeyma, Otulfi, Fymskina, Eksunbi
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 815610-63-0
- Unique Ingredient Identifier
- FU77B4U5Z0
- Background
Ustekinumab is a human immunoglobulin (Ig) G1 kappa monoclonal antibody directed against interleukin(IL)-12 and IL-23, which are cytokines that are involved in immune and inflammatory responses. It was generated via recombinant human IL-12 immunization of human Ig (hu-Ig) transgenic mice. It is a targeted biologic disease-modifying anti-rheumatic drug (bDMAR...
- Indication
Ustekinumab is indicated for the management of moderate to severe plaque psoriasis in patients 6 years of age and older who are candidates for phototherapy or systemic therapy. In adult patients, it is also indicated for the management of active psoriatic arthritis (PsA) alone or in combination with methotrexate, moderately to severely active Crohn’s disease...
- Associated Conditions
- Severe Plaque psoriasis, Ulcerative Colitis, Active Severe, Active Psoriatic arthritis, Moderate Plaque psoriasis, Moderate Ulcerative colitis, Moderate, active Crohn´s Disease, Severe, active Crohn´s Disease
- Associated Therapies
- -
Celltrion's Actemra biosimilar wins approval in Korea
Celltrion's biosimilar for Roche's Actemra (tocilizumab), Avtozma, approved by Korea's Ministry of Food and Drug Safety for RA, sJIA, and pJIA. Also received positive opinion from EMA's CHMP and completed FDA application, making Celltrion the first to secure biosimilar approval for Actemra in Korea.
FDA Approves Seventh Ustekinumab Biosimilar to Reference Stelara
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.
FDA Approves Seventh Stelara Biosimilar, Steqeyma
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.
FDA Approves Celltrion's Stelara Biosimilar for Multiple Indications
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.
FDA Approves Steqeyma: The Seventh Stelara Biosimilar
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.
Celltrion's Steqeyma nabs FDA approval as seventh Stelara biosimilar
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.
FDA Approves Seventh Ustekinumab Biosimilar
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.
U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA
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.
Drug Development Updates
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