Alvotech biosimilar receives EC marketing approval
Esme Needham | November 26, 2025 | News story | Research and Development | Alvotech, Immunology, Inflammatory disease, Rheumatology
The European Commission (EC) has granted marketing authorisation for Gobivaz, Alvotech’s first-in-market biosimilar of Simponi (golimumab), which is used for the treatment of conditions such as ulcerative colitis and rheumatoid arthritis.
Gobivaz has been granted approval across the European Economic Area (EEA) for the treatment of ulcerative colitis, axial spondyloarthritis, psoriatic arthritis with or without methotrexate, and rheumatoid arthritis in combination with methotrexate. It has also been approved for the treatment of juvenile idiopathic arthritis in children 2 years and older in combination with methotrexate.
It is a monoclonal antibody that inhibits tumour necrosis factor alpha, high levels of which have been associated with several chronic inflammatory diseases.
Evidence supporting the EC’s approval included clinical and pharmacokinetic studies carried out by Alvotech, which found positive results in a comparison between the safety, efficiency and tolerability of Gobivaz and Simponi.
Alvotech and Advanz Pharma’s partnership specifies that Alvotech is responsible for the development and supply of Gobivaz, while Advanz Pharma holds the EEA and UK registration and exclusive commercialisation rights to the drug.
“This approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases,” said Steffen Wagner, CEO of Advanz Pharma.
Robert Wessman, chairman and CEO of Alvotech, added: “This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma.”
Alvotech is a global biotech company focusing on developing biosimilar medicines.
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