Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe,  announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz^®, Alvotech’s biosimilar to Simponi^® (golimumab).

The authorizations cover Gobivaz^® 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats, for the treatment of adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and for the treatment of juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate. The approvals apply across the European Economic Area. The EC approval follows the positive opinion issued in September by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

“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,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.

“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,” said Steffen Wagner, Chief Executive Officer, Advanz Pharma.

Under the partnership between Alvotech and Advanz Pharma, Alvotech is responsible for the development and commercial supply of Gobivaz^®, while Advanz Pharma holds the registration and exclusive commercialization rights in the EEA and the UK.

The EC approval of Gobivaz^® was based on a totality of evidence, including analytical and clinical data. In April 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between its biosimilar candidate AVT05 and the reference product Simponi® in patients with moderate to severe rheumatoid arthritis (clintrials.gov/study/NCT05842213). In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi^® in healthy adult participants (clintrials.gov/study/NCT05632211).