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| Press Release
Related News:- Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
