By: IPP Bureau
Last updated : November 24, 2025 4:29 pm
Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis
Alvotech, a global biotech company specializing in biosimilars, and UK-based Advanz Pharma have bagged the European Commission's marketing approval for Gobivaz, the first biosimilar to Simponi (golimumab).
The approval of Gobivaz across the European Economic Area (EEA) strengthens the Alvotech-Advanz portfolio and represents a significant step in increasing patient access to affordable, high-quality biologics for immune-mediated diseases across the continent.
The approval covers 50 mg/0.5 mL and 100 mg/mL doses, available in pre-filled syringes with passive needle safety guards and autoinjector formats.
Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis, as well as children aged 2 years and older with juvenile idiopathic arthritis in combination with methotrexate.
"This milestone marks the second biosimilar approved through our partnership with Advanz Pharma and strengthens our presence in Europe,” said Robert Wessman, Chairman and CEO of Alvotech.
“As the first biosimilar to Simponi approved in the European market, Gobivaz will expand access to high-quality biologics for patients with immune-mediated diseases and provide value to healthcare systems throughout the region.”
Steffen Wagner, CEO of Advanz Pharma, added: “We welcome the EC approval of Gobivaz, a key milestone in our partnership with Alvotech. Expanding access to high-quality biosimilars is central to our mission, and this approval enables us to offer a valuable new treatment option to patients across Europe.”
Under their partnership, Alvotech handles the development and commercial supply of Gobivaz, while Advanz Pharma manages registration and exclusive commercialization rights in the EEA and the UK.
The EC approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2025 and is based on a comprehensive body of evidence, including analytical, clinical, and pharmacokinetic data.
In April 2024, Alvotech reported positive top-line results from a confirmatory clinical study demonstrating comparable efficacy, safety, and immunogenicity between Gobivaz and Simponi in patients with moderate to severe rheumatoid arthritis.
Earlier, in November 2023, pharmacokinetic studies confirmed Gobivaz’s equivalence to Simponi in healthy adults.