Alvotech announced that the European Commission has granted marketing authorisation for Gobivaz, its biosimilar to the reference drug Simponi (golimumab). The approval covers both 50 mg/0.5 mL and 100 mg/mL formulations in pre‑filled syringe and autoinjector formats, and it applies to rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and juvenile idiopathic arthritis in children two years and older.
The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2025 and is based on extensive analytical and clinical data, including confirmatory study topline results announced in April 2024. Gobivaz is the first Simponi biosimilar to receive approval in the European market and the second biosimilar to be approved through Alvotech’s partnership with Advanz Pharma, which holds registration and exclusive commercialization rights in the European Economic Area and the United Kingdom.
Alvotech’s CEO, Robert Wessman, said the approval “strengthens the commercial presence we are building in Europe and expands access to high‑quality, cost‑effective biologic medicines for patients with immune‑mediated diseases.” Advanz Pharma’s CEO, Steffen Wagner, added that the milestone “enables us to offer patients across Europe a valuable new treatment option for immune‑mediated diseases.” The partnership model allows Alvotech to focus on development and manufacturing while Advanz brings its commercial expertise to market the product.
The approval expands Alvotech’s pipeline and supports its goal of becoming a leading global biosimilar provider. By adding Gobivaz to its portfolio, the company gains a new revenue stream in a high‑margin therapeutic area and positions itself to capture market share from the originator product, Simponi, as biosimilar competition intensifies across the TNF‑α inhibitor class.
The regulatory milestone also reinforces the strategic alliance between Alvotech and Advanz Pharma, underscoring the value of their joint approach to bringing high‑quality biosimilars to patients in Europe and beyond.
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