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Samsung Bioepis’ PYZCHIVA Approved by FDA as Biosimilar of Stelara

PYZCHIVA has been approved for the treatment of patients with moderate to severe plaque psoriasis.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Samsung Bioepis’ PYZCHIVA (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Johnson & Johnson’s immunotherapy Stelara (ustekinumab). PYZCHIVA has been approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s d...

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