U.S. License Holder:
Celltrion
Date of License:
December-17-2024
Last Update:
Dec-31-2024
FDA-Approved Indications
STEQEYMA (ustekinumab-stba) is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Adult patients with:
Moderate to severe plaque psoriasis (PsO) 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).
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
SteQeyma® (Celltrion) (July-2024)
Biosimilars Approved In The E.U.
SteQeyma® (Celltrion) (August-2024)
Biosimilars Approved In South Korea
SteQeyma® (Celltrion) (June-2024)
