Alvotech and Advanz Pharma have announced the European Commission’s (EC) marketing authorisations for Gobivaz, a biosimilar to Simponi (golimumab), across the European Economic Area (EEA).
The authorisations cover Gobivaz in both 100mg/ml and 50mg/0.5ml formulations, provided in pre-filled syringes with autoinjector formats and passive needle safety guards, to treat adults with axial spondyloarthritis, psoriatic arthritis (with or without methotrexate).
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It can also be used for treating rheumatoid arthritis in combination with methotrexate, and ulcerative colitis.
Gobivaz can also treat juvenile idiopathic arthritis treatment in children aged two years and above when used in combination with methotrexate.
The approval from the EC comes after a favourable opinion in September 2025 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Under the collaboration between Advanz Pharma and Alvotech, the former retains the registration and exclusive rights to commercialisation within the EEA and the UK, while Alvotech will undertake the commercial supply and development of Gobivaz.
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By GlobalDataThe EC granted its approval on the basis of clinical and analytical evidence.
In April 2024, Alvotech reported positive top-line findings from a confirmatory clinical trial that compared the immunogenicity, efficacy and safety of the biosimilar candidate AVT05 (golimumab) with the reference medicine Simponi in patients with moderate to severe rheumatoid arthritis.
AVT05 is approved as Golimumab BS (golimumab) in Japan, and in the European Economic Area, as Gobivaz (golimumab).
Advanz Pharma CEO Steffen Wagner stated: “We welcome the EC approval of Gobivaz, an important milestone in our partnership with Alvotech.
“Expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases.”
In November 2025, Alvotech and Advanz Pharma announced the receipt of marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency for all four formulations of Gobivaz.
