REYKJAVIK, Iceland and LONDON — November 20, 2025 — Leads & Copy — Alvotech and Advanz Pharma announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab).
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).
Robert Wessman, Chairman and Chief Executive Officer of Alvotech, said this milestone marks the second biosimilar to receive approval through their partnership with Advanz Pharma and further strengthens the commercial presence they are building in Europe. Wessman added that as the first biosimilar to Simponi® (golimumab) to gain approval in the European market, they 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.
Steffen Wagner, Chief Executive Officer, Advanz Pharma, said they welcome the EC approval of Gobivaz®, an important milestone in their partnership with Alvotech. Wagner added that expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables them to offer patients across Europe a valuable new treatment option for immune-mediated diseases.
Under the partnership, 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.
The EC approval of Gobivaz® was based on a totality of evidence, including analytical and clinical data. In April 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between its biosimilar candidate AVT05 and the reference product Simponi® in patients with moderate to severe rheumatoid arthritis (clintrials.gov/study/NCT05842213). In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants (clintrials.gov/study/NCT05632211).
AVT05 (golimumab) has been approved as Golimumab BS (golimumab) in Japan and as Gobivaz (golimumab) in the European Economic Area. Dossiers are under review in multiple countries globally. Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis [1].
Sources: [1] Simponi product information
Use of Trademarks: Simponi® is a registered trademark of Johnson & Johnson. Gobivaz® is a trademark of Advanz Pharma.
Alvotech Global Communications and Investor Relations Contact: Benedikt Stefansson, alvotech.ir@alvotech.com
Advanz Pharma Global Corporate Communications Contact: Courtney Baines, courtney.baines@advanzpharma.com
Source: Alvotech
