The European Commission has approved Alvotech and Advanz Pharma’s Gobivaz, the first biosimilar to Simponi (golimumab) authorized in the European Economic Area. The approval covers multiple formulations, including pre-filled syringes and autoinjectors, for treating rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and juvenile idiopathic arthritis.
The decision follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use in September. Alvotech CEO Robert Wessman said the milestone strengthens the company’s European presence and supports wider access to biologic medicines. Advanz Pharma CEO Steffen Wagner noted that the approval advances their mission to expand high-quality biosimilar access across Europe.
Under their partnership, Alvotech develops and manufactures Gobivaz, while Advanz Pharma holds exclusive commercialization rights in the EEA and UK. The approval is backed by analytical and clinical data, including successful efficacy and pharmacokinetic studies.