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
-
Clinical Trials
Related News
managedhealthcareexecutive.com
·

Stelara Biosimilar Otulfi Approved by FDA to Treat Multiple Autoimmune Disorders

FDA approves Stelara biosimilar Otulfi (ustekinumab-aauz) for Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi, available in subcutaneous and intravenous formulations, targets interleukin-12 and interleukin-23. It will launch in the U.S. by Feb. 22, 2025, and is also approved in the EU. Common adverse reactions include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
empr.com
·

Ustekinumab Biosimilar Otulfi Gets FDA Approval

FDA approves Otulfi™ (ustekinumab-aauz), a biosimilar to Stelara®, for treating moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn disease or ulcerative colitis. Approval based on phase 3 VESPUCCI study showing comparable efficacy and safety. Available in 45mg/0.5mL, 90mg/mL prefilled syringes, and 130mg/26mL vial for IV infusion, expected by Feb 2025.

Related Clinical Trials:

A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis
finance.yahoo.com
·

Fresenius Kabi wins FDA approval for Stelara biosimilar Otulfi

Fresenius Kabi and Formycon receive FDA approval for Otulfi, a Stelara biosimilar, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi is the fourth Stelara biosimilar approved in the US, following Amgen’s Wezlana, Alvotech and Teva’s Selarsdi, and Samsung Bioepis and Sandoz’s Pyzchiva. Stelara sales are expected to drop to $1.2bn by 2030 due to biosimilar competition.
hcplive.com
·

FDA Approves Stelara Biosimilar Ustekinumab-aauz (Otulfi)

FDA approves Fresnius Kabi and Formycon’s ustekinumab biosimilar, ustekinumab-aauz (Otulfi), for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresnius Kabi’s fourth biosimilar product in the U.S. market, reflecting their commitment to broadening their biopharma portfolio globally.
drugs.com
·

FDA Approves Otulfi (ustekinumab-aauz), a Biosimilar to Stelara

Fresenius Kabi and Formycon AG announced FDA approval of Otulfi™ (ustekinumab-aauz), a ustekinumab biosimilar referencing Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi's fourth biosimilar in the U.S., aligning with their Vision 2026 growth strategy to expand their biopharma portfolio globally.
healio.com
·

FDA approves Otulfi as fourth Stelara biosimilar for chronic inflammatory diseases

FDA approves Otulfi, a fourth Stelara biosimilar, for chronic inflammatory diseases including Crohn’s and ulcerative colitis, expected to be available in the U.S. by February.
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