Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Approval
Shots:
- The US FDA has approved Selarsdi (ustekinumab-aekn) injection (SC) for adults & pediatric patients (≥6yrs.) with moderate to severe plaque Pso & active PsA. Teva will commercialize it in the US as per an agreement b/w Teva & Alvotech
- The approval was based on 2 studies incl. AVT04-GL-301 trial assessing the efficacy, safety & immunogenicity of Selarsdi vs Stelara in moderate to severe chronic plaque Pso patients (n=581) & P-I (AVT04-GL-101) trial assessing the PK, safety, tolerability & immunogenicity of Selarsdi (45mg/0.5mL, SC) vs Stelara in healthy adults (n=294)
- Both companies have entered into a settlement & license agreement with J&J (Stelara’s manufacturer) to market Selarsdi across the US in Feb 2025
Ref: Teva | Image: Teva
Related News:- Teva Reports Results from the P-III Study of Ajovy (fremanezumab) to Prevent Migraine in Chinese Patients
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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.
