Alvotech and Advanz announce MHRA marketing authorisations for Gobivaz

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The therapy is indicated for the treatment of rheumatoid arthritis and psoriatic arthritis. Alvotech and Advanz Pharma have revealed the receipt of marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for all four formulations of Gobivaz – Alvotech’s biosimilar to Simponi (golimumab).

The authorisations are granted for Gobivaz in 50 mg/0.5 mL and 100 mg/mL formulations, available in pre-filled syringes and autoinjectors. Evidence suggests that go deeper with GlobalData

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The medication is indicated for the treatment of psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, axial spondylarthritis and ulcerative colitis in adults throughout the UK.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favourable opinion recommending Gobivaz’s approval throughout the European Economic Area. Under the collaboration, Alvotech is tasked with the development and commercial supply of Gobivaz, while Advanz Pharma possesses the exclusive rights for its commercialisation and registration in the UK and Europe. Alvotech chief scientific and technical officer Joseph McClellan stated: “This approval further validates the strength and capabilities of Alvotech’s integrated development and manufacturing platform for biosimilars. GlobalData Strategic Intelligence US Tariffs are shifting – will you react or anticipate?

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“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.”
Advanz Pharma chief medical officer Nick Warwick stated: “With these approvals, we are now well-positioned 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.”
Golimumab is a monoclonal antibody that targets and inhibits tumour necrosis factor alpha (TNF alpha).

Sources indicate that increased levels of TNF alpha have been implicated in chronic inflammatory conditions such as ankylosing spondylitis, rheumatoid arthritis and psoriatic arthritis. In May 2025, Alvotech and Advanz Pharma broadened their commercial collaboration with an agreement to include three additional biosimilar candidates for commercialisation in Europe. Sign up for our daily news round-up! According to reports that give your business an edge with our leading industry insights.

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As the situation continues to develop, industry participants in Healthcare will likely monitor outcomes closely.

— Based on reporting from pharmaceutical-technology.com

💡 Key Industry Insights

Medical research and pharmaceutical developments remain critical areas of investment and growth.

Specifically regarding health insurance, market observers note continuing evolution in service delivery, pricing models, and customer engagement strategies that merit close attention from industry stakeholders.

Market Impact: These developments in medical treatment may significantly influence market dynamics. Industry experts recommend monitoring these trends closely for strategic planning purposes.

Analysis Note: This comprehensive overview synthesizes current market intelligence from pharmaceutical-technology.com regarding surgery and related sectors. Stay informed about ongoing developments in this rapidly evolving landscape.