U.S. License Holder:
Samsung Bioepis / Sandoz
Date of License:
June-28-2024 (Interchangeable)
Last Update:
Oct-23-2024
FDA-Approved Indications
PYZCHIVA (ustekinumab-ttwe) 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).
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Pyzchiva® (Sandoz / Samsung Bioepis) (April-2024)
Biosimilars Approved In South Korea
Epyztek (Samsung Bioepis) (April-2024)