Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)
Shots:
- The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC
- Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability & immunogenicity among healthy subjects & P-III, depicting the similarity in moderate to severe plaque PsO patients at 28wks.
- Pyzchiva, developed by Samsung, will be commercialized by Sandoz in the US as per an agreement signed in 2023 covering the US, Canada, EEA, Switzerland & UK. The license period will start on Feb 22, 2025 in the US, as per the settlement with Janssen
Ref: Samsung Bioepis | Image: Samsung Bioepis
Related News:- Samsung Bioepis Receives EC’s Marketing Authorization for Pyzchiva (Biosimilar, Stelara) to treat Autoimmune disorders
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
