Alvotech and its partner Advanz Pharma announced that the UK Medicines and Healthcare products Regulatory Agency granted marketing authorisations for Gobivaz, a biosimilar to the biologic Simponi (golimumab). The authorisations cover all four presentations—50 mg/0.5 mL and 100 mg/mL in both pre‑filled syringe and autoinjector formats—for rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis.
The approval expands Alvotech’s biosimilar portfolio into the inflammatory‑disease segment, complementing its existing Humira and Stelara biosimilars. Under the partnership, Alvotech will develop and supply Gobivaz, while Advanz Pharma holds registration and exclusive commercialisation rights in Europe and the UK. The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on September 18 2025, paving the way for the UK approval and signalling regulatory confidence in the product’s quality and efficacy.
Globally, the golimumab market was valued at approximately $20.1 billion in 2023 and is projected to reach $39.3 billion by 2031, a CAGR of 5%. Gobivaz therefore targets a substantial opportunity in the United Kingdom and across Europe, where demand for biologics in rheumatoid and psoriatic arthritis remains high. While other golimumab biosimilars are in development, Gobivaz’s early entry into the UK market positions Alvotech to capture market share before additional competitors launch.
Alvotech reported an 82% year‑over‑year revenue growth over the last twelve months, underscoring the company’s rapid expansion in the biosimilar space. The new approval is expected to contribute to this momentum by adding a new revenue stream in a high‑margin therapeutic area, reinforcing the company’s strategy of scaling its manufacturing platform and expanding its product pipeline.
Joseph McClellan, Chief Scientific and Technical Officer, said the approval “further validates the strength and capabilities of Alvotech’s integrated development and manufacturing platform for biosimilars. We look forward to increasing access to an important biologic for the treatment of various immune‑mediated diseases by making Gobivaz available to patients in collaboration with our partner Advanz Pharma.” Nick Warwick, Chief Medical Officer at Advanz Pharma, added that the approvals “position us well to make Gobivaz available to patients and healthcare professionals in the UK, helping to broaden access to an important biologic treatment for immune‑mediated diseases.”
The UK launch is expected shortly after the regulatory approval, with Advanz Pharma outlining a go‑to‑market strategy that will leverage its existing commercial network. While the company has not issued new financial guidance, the addition of Gobivaz is anticipated to strengthen Alvotech’s long‑term growth trajectory by diversifying its product portfolio and deepening its presence in the inflammatory‑disease market.
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