Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab)

Core Insights - The European Commission has granted marketing authorizations for Gobivaz®, a biosimilar to Simponi® (golimumab), developed by Alvotech in partnership with Advanz Pharma [1][2][3] Group 1: Product Approval - Gobivaz® is approved in two formats: 50 mg/0.5 mL and 100 mg/mL, for treating various conditions including rheumatoid arthritis and juvenile idiopathic arthritis [2][6] - The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use [2][6] Group 2: Partnership and Market Strategy - The approval of Gobivaz® marks the second biosimilar approved through the partnership between Alvotech and Advanz Pharma, enhancing their commercial presence in Europe [3][4] - Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds registration and exclusive commercialization rights in the EEA and the UK [5] Group 3: Clinical Evidence - The EC approval was based on comprehensive evidence, including analytical and clinical data, with positive results from studies comparing AVT05 (Gobivaz®) to Simponi® [6][7] - Alvotech announced positive top-line results from a confirmatory clinical study and a pharmacokinetic study assessing AVT05's efficacy and safety [6][7] Group 4: Company Background - Alvotech focuses on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline of eight disclosed candidates [9][10] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [11][10]