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. The approvals apply across the European Economic Area. The EC approval follows the positive opinion issued in September by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

“This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma and further strengthens the commercial presence we are building in Europe. As the first biosimilar to Simponi (golimumab) to gain approval in the European market, we are committed to expanding access to high quality biologic medicines for people living with immune-mediated diseases while providing value to healthcare systems throughout the region” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.

The partnership

Under the partnership between Alvotech and Advanz Pharma, Alvotech is responsible for the development and commercial supply of Gobivaz, while Advanz Pharma holds the registration and exclusive commercialization rights in the EEA and the UK.