Shots: 

• The EC has granted marketing authorization for Pyzchiva (Biosimilar, Stelara) to treat autoimmune disorders in gastroenterology, dermatology, and rheumatology 
• The approval was based on P-I & P-III studies of Pyzchiva vs Stelara. P-I trial assessing the PK, safety, tolerability & immunogenicity in healthy volunteers, and  P-III trial assessing the efficacy, safety & PK profile up to 28wks., in moderate to severe plaque PsO patients  
• In Sep’23, Sandoz and Samsung Bioepis signed development and commercialization agreement for the US, Canada, UK, EEA, and Switzerland, following which Sandoz will be responsible for PYZCHIVA’s commercialization 

Ref: Samsung Bioepis | Image: Samsung Bioepis

Related News:- Samsung Bioepis Reports the Initiation of the P-I Trial Evaluation of SB27 (biosimilar, pembrolizumab) for the Treatment of Lung Cancer

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