Key takeaways:
- EC approval of Gobivaz gives Alvotech and Advanz Pharma a stronger foothold in Europe’s competitive biosimilar segment.
- The authorisation widens the companies’ reach in immune-mediated therapies by adding a multi-indication biosimilar to their portfolio.
- Gobivaz’s clinical and pharmacokinetic evidence base reinforces its positioning as a comparable treatment option across several immune-mediated conditions.
Alvotech and Advanz Pharma have secured European Commission marketing authorisations for Gobivaz, marking the first approval in the European Economic Area for a biosimilar referencing Simponi (golimumab).
The green light extends to Gobivaz 50 mg/0.5 mL and 100 mg/mL, which will be available in both pre-filled syringe formats equipped with a passive needle safety guard as well as autoinjector. The therapy is cleared for adult patients with rheumatoid arthritis when used with methotrexate, psoriatic arthritis either in combination with or without methotrexate, axial spondyloarthritis, ulcerative colitis, and for children aged two or older with juvenile idiopathic arthritis in combination with methotrexate.
Robert Wessman, Chairman and Chief Executive Officer of Alvotech, said: “This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma and further strengthens the commercial presence we are building in Europe. As the first biosimilar to Simponi (golimumab) to gain approval in the European market, we are committed to expanding access to high quality biologic medicines for people living with immune-mediated diseases while providing value to healthcare systems throughout the region.”
Steffen Wagner, Chief Executive Officer of Advanz Pharma, added: “We welcome the EC approval of Gobivaz, an important milestone in our partnership with Alvotech. Expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases.”
The collaboration between Alvotech and Advanz outlines a clear division of responsibilities: Alvotech oversees development and commercial supply, while Advanz Pharma manages registration and has exclusive commercialisation rights for the EEA and the UK.
The EC decision rests on a totality of evidence, supported by clinical and pharmacokinetic studies that demonstrated the biosimilar’s comparability. With this authorisation now in place, the two companies are positioned to further scale their biosimilar footprint across Europe’s immune-mediated disease landscape.
