U.S. License Holder:
Centocor Ortho Biotech Inc. (Janssen Biotech, Inc.)
Date of License:
September-25-2009 [September-23-2016]
Last Update:
Sep-30-2024
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);
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;
Active psoriatic arthritis (PsA).
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Wezlana: Amgen (October-2023 Interchangeable) Selarsdi: Alvotech / Teva (April-2024) Pyzchiva® (Samsung Bioepis / Sandoz) (June-2024 Interchangeable)
aBLA / 505(b)(2) Accepted by FDA
CT-P43: Celltrion (June-2023) DMB-3115 (Accord BioPharma) (January-2024) Bmab 1200 (Biocon) (Announced February-2024) BAT2206: Bio-Thera Solutions (July-2024)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Jamteki (Alvotech / JAMP Pharma) (November-2023) Steqeyma (Celltrion) (July-2024)Wezlana (Amgen) (December-2023)
Biosimilars Approved In The E.U.
Otulfi (Fresenius Kabi / Formycon (September-2024)Pyzchiva® (Sandoz / Samsung Bioepis) (April-2024) SteQeyma® (Celltrion) (August-2024) Uzpruvo® (Alvotech / STADA Arzneimittel) (January-2024)
Biosimilars Approved In Japan
AVT04 (Alvotech / Fuji Pharma) (September-2023)
Biosimilars Approved In South Korea
Epyztek (Samsung Bioepis) (April-2024) Steqeyma (Celltrion) (June-2024)