U.S. License Holder:
Centocor Ortho Biotech Inc. (Janssen Biotech, Inc.)
Date of License:
September-25-2009 [September-23-2016]
Last Update:
Sep-23-2023
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) Accepted by FDA
ABP 654: Amgen (November-2022) AVT04: Alvotech / Teva (January-2023) CT-P43: Celltrion (June-2023)