Shots:
- The EC has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis (with methotrexate), PsA (± methotrexate), ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis (with methotrexate) across 30 EEA states
- Approval was based on extensive data, incl. P-III trial of AVT05 vs reference Simponi in pts with mod. to sev. rheumatoid arthritis (data reported in Apr 2024) & P-I trial comparing AVT05 to Simponi in healthy adults (reported Nov 2023)
- Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while Advanz Pharma handles registration & holds exclusive commercialization rights in the EU
Ref: Alvotech| Image: Alvotech & Advanz Pharma | Press Release
Related News:- Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases
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