Gobivaz (golimumab biosimilar) / Advanz Pharma - LARVOL DELTA

Alvotech announces European launch of first-in-market biosimilar to Simponi (golimumab) globally by partner Advanz Pharma (Alvotech Press Release) - "Availability across EEA markets will progress in line with national pricing and reimbursement processes."

Biosimilar launch • Idiopathic Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Spondylarthritis • Ulcerative Colitis

Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz, a First-in-Market Biosimilar to Simponi (golimumab) (The Manila Times) - "The authorizations cover Gobivaz 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats, for the treatment of adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and for the treatment of juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate."

FDA approval • Idiopathic Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Alvotech and Advanz Pharma Receive Marketing Authorisations for Gobivaz, a Biosimilar to Simponi (golimumab), from the MHRA (The Manila Times) - "The authorisations cover Gobivaz 50 mg/0.5 mL and 100 mg/mL presentations in both pre-filled syringe and autoinjector formats, for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis. The approvals apply across the United Kingdom."

MHRA approval • Idiopathic Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Spondylarthritis • Ulcerative Colitis

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025 (European Medicines Agency) - "On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gobivaz, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis."

CHMP • Idiopathic Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Spondylarthritis • Ulcerative Colitis