European Medicines Agency Endorses Alvotech’s Gobivaz® for Approval

The European Medicines Agency (EMA) has moved forward with a positive recommendation for Gobivaz®, a proposed biosimilar to Simponi® (golimumab), developed by Alvotech, a biotechnology firm based in Reykjavik, Iceland. This endorsement from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is a significant step towards potential marketing approval of the biosimilar, which is intended to treat various chronic inflammatory diseases.

Advanz Pharma Holdco Limited, a UK-based global pharmaceutical company, is collaborating with Alvotech to increase the availability of this important treatment. The recommendation was publicly announced on September 22, 2025, demonstrating a proactive approach in addressing the needs of patients affected by immune-mediated conditions.

Strategic Collaboration for Enhanced Patient Access

Joseph McClellan, Chief Scientific and Technical Officer at Alvotech, expressed enthusiasm regarding the partnership with Advanz Pharma, stating, “We look forward to working with Advanz Pharma to increase access for patients and healthcare professionals to golimumab, as the reference biologic Simponi® is an important treatment option for a number of immune-mediated diseases.” This collaboration underscores a shared commitment to expanding treatment options for patients in Europe.

Simponi® is already an established treatment for a range of conditions, including rheumatoid arthritis and ulcerative colitis. The introduction of Gobivaz® is expected to provide a more accessible alternative, potentially lowering treatment costs and enhancing patient access across Europe.

Implications for Healthcare Providers and Patients

The CHMP’s positive opinion is a critical milestone in the regulatory process, paving the way for Alvotech and Advanz Pharma to engage with healthcare professionals and stakeholders in the region. If approved, Gobivaz® could be a game-changer for patients dealing with chronic inflammatory diseases, offering a viable option that aligns with the growing demand for biosimilar therapies.

With the global push towards more affordable healthcare solutions, the approval of biosimilars like Gobivaz® not only benefits patients but also supports healthcare systems by providing alternatives to high-cost biological treatments.

As the situation develops, both Alvotech and Advanz Pharma remain committed to ensuring that healthcare providers can effectively integrate this new biosimilar into their treatment protocols, emphasizing patient care and accessibility. The anticipated approval of Gobivaz® marks an important chapter in the ongoing evolution of biologic therapies and their role in chronic disease management.