A new version of the medicine Simponi, called Gobivaz, has been approved in Europe. This new version is for people with certain immune system diseases. It was made by a company called Alvotech and will compete with the original Simponi, which is made by Johnson & Johnson. The new medicine comes in two forms: a pre-filled syringe with a safety guard and an autoinjector. It can be used to treat adults with rheumatoid arthritis (when taken with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, ulcerative colitis, and children over two years old with juvenile idiopathic arthritis (when taken with methotrexate). Simponi works by blocking a substance in the body called tumor necrosis factor alpha (TNF alpha), which is linked to several long-term inflammatory diseases, including rheumatoid arthritis. The approval of Gobivaz was based on various pieces of evidence, including data from a study Alvotech did in 2023. This study compared the effects, safety, and how well people tolerated the new medicine compared to Simponi in healthy adults. In 2024, Alvotech also shared results from another study that compared how well Gobivaz and Simponi worked in people with moderate to severe rheumatoid arthritis. This information was also part of the approval process. The European Commission’s approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in September. Robert Wessman, the Chairman and CEO of Alvotech, said: “This is a big step for us. It’s the second biosimilar we’ve approved through our partnership with Advanz Pharma, and it helps us build a stronger presence in Europe. We’re committed to making high-quality biologic medicines available to people with immune-mediated diseases while also providing value to healthcare systems in the region.”