Alvotech, a global biotechnology company focused on biosimilars, and Advanz Pharma, a UK-based pharmaceutical company specializing in specialty and hospital medicines, announced that the European Commission has granted marketing authorizations for Gobivaz, Alvotech’s biosimilar to Simponi (golimumab). The approval covers the European Economic Area and includes Gobivaz 50 mg/0.5 mL and 100 mg/mL in both pre-filled syringes with passive safety guards and autoinjectors.

Gobivaz has been cleared for multiple indications: rheumatoid arthritis (with methotrexate), psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and juvenile idiopathic arthritis in children aged two and above (with methotrexate). The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Robert Wessman, chairman and chief executive officer of Alvotech, said the authorization strengthens the companies’ commercial presence in Europe and marks the first Simponi biosimilar approved in the region. Steffen Wagner, chief executive officer of Advanz Pharma, said the approval aligns with the company’s mission to expand access to high-quality biosimilars across Europe.

Alvotech led development and will supply Gobivaz, while Advanz Pharma holds exclusive commercialization rights in the EEA and the UK. Approval was supported by analytical data and clinical studies demonstrating comparable efficacy, safety, pharmacokinetics, and immunogenicity to Simponi.

Gobivaz is already approved in Japan, with dossiers under review in several other countries.