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
- -
South Korean company Dong-A ST wins FDA approval for Stelara biosimilar
Dong-A ST received FDA approval for Imuldosa, a Stelara biosimilar, amidst a crowded market of approved but unlaunched biosimilars. Stelara's sales are expected to decline post-2023 patent expiry, with biosimilars like Amgen's Wezlana and Samsung Bioepis's Pyzchiva set to launch in 2025. Stelara, an IL-12/IL-23 inhibitor, treats psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.
Related Clinical Trials:
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Johnson & Johnson proposed changes to the 340B drug discount program, but backed down after HRSA deemed them inconsistent with the statute. The 340B program, established in 1992, aims to help underserved communities by allowing eligible hospitals and clinics to purchase outpatient prescription medications at discounts. Recent regulatory developments include FDA approvals for Exact Sciences' Cologuard Plus, Partners Fresenius Kabi and Formycon's Otulfi, Eli Lilly's Retevmo, Sanofi and Regeneron's Dupixent, Bristol Myers Squibb's Cobenfy, and others. Additionally, Pfizer withdrew Oxbryta from the market due to safety concerns.
Fresenius Kabi, Formycon receive FDA nod for Stelara biosimilar
Fresenius Kabi and Formycon AG received FDA approval for Otulfi (ustekinumab-aauz), a biosimilar of 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. market, aligning with their Vision 2026 strategy to expand their biopharma portfolio globally.
FDA Approves Fresenius Kabi, Formycon's Stelara Biosimilar for Multiple Inflammatory Diseases
FDA approves Fresenius Kabi’s and Formycon’s Otulfi, a biosimilar to Stelara, for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi’s fourth biosimilar approval by the FDA, aligning with its Vision 2026 strategy to expand its biopharma market presence.
FDA grants approval for Fresenius-Formycon's biosimilar Otulfi
FDA approves Fresenius Kabi and Formycon's Otulfi (ustekinumab-aauz), a ustekinumab biosimilar to Stelara, for treating Crohn’s disease, moderate to severe plaque psoriasis, ulcerative colitis, and active psoriatic arthritis. Otulfi is available as subcutaneous and intravenous formulations, not indicated for hypersensitivity to ustekinumab.
Fresenius Kabi, Formycon secure FDA approval for Stelara biosimilar Otulfi
Fresenius Kabi and Formycon receive FDA approval for Otulfi, a biosimilar to J&J's Stelara, indicated for Crohn's disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi is Fresenius Kabi's fourth biosimilar in the US, supported by comprehensive data showing comparable efficacy, safety, pharmacokinetics, and immunogenicity to Stelara.
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