Managed Healthcare Executive July 1, 2024
Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) will be available beginning Feb. 22, 2025 and will be marketed by Sandoz.
The FDA has approved the biologics license application (BLA) for Pyzchiva (ustekinumab-ttwe) as a biosimilar to Janssen’s Biotech’s Stelara (ustekinumab). Pyzchiva marketing begins Feb. 22, 2025, based on a licensing agreement with Janssen.
Developed by Samsung Bioepis, Pyzchiva will be available as a subcutaneous injection and an intravenous infusion. It has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Additionally, a provisional determination was granted for Pyzchiva’s interchangeability.
Pyzchiva will be commercialized by Sandoz in the...
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