FDA Nod for PYZCHIVA (ustekinumab-ttwe), Samsung Bioepis’ Stelara Biosimilar
The Dermatology Digest
JULY 1, 2024
The FDA’s approval of PYZCHIVA is based on a totality of evidence including analytical, non-clinical and clinical data demonstrating biosimilarity to Stelara, with no clinically meaningful differences in terms of safety, purity and potency. PYZCHIVA, developed by Samsung Bioepis, will be commercialized by Sandoz in the United States.
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