European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech's Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner

Core Viewpoint - Alvotech and Advanz Pharma announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for Gobivaz®, a biosimilar to Simponi® (golimumab), which is used to treat chronic inflammatory diseases [1][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes eight disclosed biosimilar candidates targeting various diseases [9]. - Advanz Pharma is a UK-based global pharmaceutical company specializing in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [11]. Product Details - Gobivaz® is proposed in two formulations: 50 mg/0.5 mL and 100 mg/mL, intended for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis [4]. - The product is still under EMA regulatory review, with a final decision pending from the European Commission [4]. Clinical Study Results - Alvotech previously announced positive top-line results from a clinical study comparing the efficacy, safety, and immunogenicity of its biosimilar candidate AVT05 with Simponi® in patients with moderate to severe rheumatoid arthritis [6]. - A pharmacokinetic study also showed positive results for AVT05 compared to Simponi® in healthy adult participants [6]. Strategic Partnership - Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds exclusive rights for commercialization in Europe [5].