Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases
Shots:
- The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states
- In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts with mod. to sev. rheumatoid arthritis (reported Apr 2024), & similar PK, safety, & tolerability 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| Press Release
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