European Medicines Agency Endorses Alvotech’s Gobivaz® for Approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Gobivaz®, a proposed biosimilar to Simponi® (golimumab) developed by Alvotech. This significant endorsement was announced on September 22, 2025, by Alvotech, a biotechnology company based in Reykjavik, Iceland, and Advanz Pharma Holdco Limited, a London-based pharmaceutical firm focused on specialty and rare disease medicines.

Gobivaz® is designed to treat several chronic inflammatory diseases, offering an alternative to Simponi®, which is a biologic medicine widely used for conditions such as rheumatoid arthritis and ulcerative colitis. The positive opinion from the CHMP marks a crucial step toward enhancing patient access to effective treatments in Europe.

Joseph McClellan, Chief Scientific and Technical Officer of Alvotech, expressed optimism about the collaboration with Advanz Pharma. He stated, “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.”

Implications for Patients and Healthcare Providers

The recommendation from the EMA holds significant implications for patients suffering from immune-mediated diseases. Biosimilars like Gobivaz® are designed to be highly similar to their reference biologics, potentially offering a more cost-effective option while maintaining efficacy and safety standards. This can lead to increased availability and affordability of critical treatments.

As healthcare systems globally seek to manage costs while ensuring patient access to necessary medications, the approval of biosimilars is becoming increasingly important. The introduction of Gobivaz® could potentially improve treatment options for patients and relieve some financial pressures on healthcare providers.

Next Steps in the Approval Process

Following the CHMP’s positive opinion, the recommendation will be forwarded to the European Commission, which has the authority to grant marketing authorization for medicines in the European Union. If approved, Gobivaz® will join the growing list of biosimilars available in the market, further diversifying treatment options for healthcare professionals.

Both Alvotech and Advanz Pharma are prepared for the next stages of the approval process and are committed to ensuring that Gobivaz® becomes a valuable option for patients across Europe. The companies aim to facilitate a smoother transition from reference biologics to biosimilars, thereby enhancing healthcare outcomes in the region.

With the continued advancement in biosimilar development, the healthcare landscape is poised for transformation, allowing for improved patient care and expanded access to essential treatments.