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| Press Release
Related News:- Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea)
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