Reykjavik & London, November 2025 Alvotech and Advanz Pharma have received marketing approval across the European Economic Area (EEA) for Gobivaz, the first biosimilar to golimumab, marking a major advancement in access to high-quality anti-TNF biologics for autoimmune diseases. Gobivaz is approved for all the same indications as the reference monoclonal antibody, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and ulcerative colitis. With autoimmune conditions rising globally, Gobivaz represents a strategic step toward expanding biologic access while reducing healthcare burdens associated with chronic inflammatory disorders.
Science Significance
The approval of Gobivaz underscores the scientific excellence required to develop a biosimilar to a complex monoclonal antibody such as golimumab. Achieving biosimilarity involves comprehensive evaluations of analytical structure, receptor binding, immune pathway activation, pharmacokinetics, and clinical performance. Gobivaz has demonstrated equivalent efficacy, safety, and immunogenicity, supporting its scientific credibility and confirming that it performs indistinguishably from the reference product. The biosimilar’s successful development reflects advancements in protein manufacturing, glycosylation control, and biologic engineering, further reinforcing Europe’s leadership in highly regulated biosimilar science.
Regulatory Significance
The EEA approval is grounded in some of the world’s most rigorous biosimilar standards. Europe’s regulatory environment remains a global model for evaluating biosimilars, ensuring that only products with exhaustive comparability data achieve market entry. Gobivaz’s approval grants access across all 30 EEA member states, integrating the biosimilar into national formularies, reimbursement systems, and hospital procurement pathways. This regulatory milestone demonstrates continued trust in biosimilar pathways and supports accelerated approval pipelines for future monoclonal antibody biosimilars.
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Business Significance
For Alvotech, the approval validates its vertically integrated biosimilar platform, elevating the company’s presence in the European biologics market. Advanz Pharma benefits from enhanced distribution opportunities, allowing rapid deployment across clinical centres specializing in autoimmune and inflammatory disorders. Gobivaz is positioned to deliver significant economic value by reducing biologic costs for health systems, expanding options for providers, and increasing market competition. The biosimilar’s introduction is expected to catalyze wider adoption of anti-TNF biosimilars, further strengthening financial sustainability within European healthcare.
Patients’ Significance
Patients with chronic autoimmune diseases often rely on lifelong therapy, which can be financially burdensome and difficult to access. Gobivaz contributes to broader therapeutic reach by offering a cost-effective, clinically equivalent alternative, enabling earlier intervention, improved adherence, and expanded access to biologic care. For individuals with progressive inflammatory disorders, consistent access to anti-TNF therapy is essential for maintaining quality of life, mobility, and long-term disease control. Gobivaz’s availability helps remove socioeconomic barriers that often limit treatment initiation for underserved populations.
Policy Significance
The approval aligns with European health-policy objectives emphasizing biosimilar uptake as a tool to enhance system sustainability and increase patient access. Policymakers across the EU continue to encourage competition in the biologics market, recognizing biosimilars as critical components of long-term healthcare planning. Gobivaz supports policy goals of reducing biologic spending without compromising therapeutic quality. Its approval further solidifies Europe’s role as the global leader in biosimilar regulation, setting the standard for international adoption frameworks.
Gobivaz’s EEA approval marks a major advancement for the European biologics ecosystem, bringing high-quality anti-TNF therapy to more patients while supporting cost-effective health-system planning. Alvotech and Advanz Pharma’s achievement demonstrates how scientific innovation, regulatory excellence, and patient-centred strategies can converge to expand access to essential therapies. This milestone represents a strong step forward for biosimilar adoption, solidifying Gobivaz’s role as a foundational treatment option across Europe.
Source: Alvotech press release
