Overview
- The EC granted marketing authorisations for Gobivaz 50 mg/0.5 mL and 100 mg/mL in pre-filled syringe with passive needle safety guard and autoinjector formats.
- Approved uses include adult rheumatoid arthritis with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis, and juvenile idiopathic arthritis from age two with methotrexate.
- The decision was based on a totality of evidence, including analytical, clinical and pharmacokinetic data, following a favorable CHMP opinion in September 2025.
- Under their agreement, Alvotech leads development and commercial supply, while Advanz holds registration and exclusive commercialization rights in the EEA and the UK.
- The companies also report UK authorisations in November 2025 covering all four Gobivaz formulations.