FDA approves Samsung Bioepis' PYZCHIVA® as a biosimilar to Stelara® for treating autoimmune diseases.
FDA approves Samsung Bioepis' PYZCHIVA® (ustekinumab-ttwe) as a biosimilar to Stelara® (ustekinumab) for treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis. PYZCHIVA will be commercialized by Sandoz in the US, with a licensing period starting in 2025. This marks Samsung Bioepis' seventh biosimilar and fourth immunology biosimilar approved by the FDA.
July 01, 2024
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