Alvotech and Advanz Pharma have received marketing authorisations from the European Commission for Gobivaz, the first biosimilar to Simponi (golimumab) to be approved in the European Economic Area.
The authorisations cover Gobivaz 50 mg/0.5 mL and 100 mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats. The treatment is approved for use in adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and in children aged two and 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, said: “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.”
Under the agreement, Alvotech is responsible for development and commercial supply, while Advanz Pharma holds registration and exclusive commercialisation rights in the EEA and the UK. The approval was based on a totality of evidence, including positive clinical and pharmacokinetic studies.
