U.S. License Holder:
Centocor Ortho Biotech Inc. (Janssen Biotech, Inc.)
Date of License:
September-25-2009 [September-23-2016]
Last Update:
Mar-08-2024
FDA-Approved Indications
STELARA (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Adult patients with:
Moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy;
Active psoriatic arthritis (PsA), alone or in combination with methotrexate;
Moderately to severely active Crohn's disease (CD);
Moderately to severely active ulcerative colitis;
Pediatric patients 6 years and older with:
Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Wezlana: Amgen (October-2023 Interchangeable)
aBLA / 505(b)(2) Accepted by FDA
AVT04: Alvotech / Teva (January-2023; Complete Response Letter October-2023) CT-P43: Celltrion (June-2023) SB17 (Samsung Bioepis / Sandoz) (Filing Date Undisclosed) DMB-3115 (Accord BioPharma) (January-2024) Bmab 1200 (Biocon) (Announced February-2024)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Jamteki (Alvotech / JAMP Pharma) (November-2023)
Biosimilars Approved In The E.U.
Uzpruvo® (Alvotech / STADA Arzneimittel) (January-2024)
Biosimilars Approved In Japan
AVT04 (Alvotech / Fuji Pharma) (September-2023)