Alvotech and Advanz Pharma get EU approval for first Simponi biosimilar to treat immune diseases

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Prime Highlights

  • Alvotech and Advanz Pharma have secured European Commission approval for Gobivaz, the first biosimilar to Simponi (golimumab) in the EEA.
  • The companies aim to expand access to biologic treatments for immune-mediated conditions across Europe.

Key Facts

  • Gobivaz is approved for adults with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis, and for children aged two and above with juvenile idiopathic arthritis.
  • Alvotech manages development and supply, while Advanz Pharma holds exclusive commercial rights in the EEA and UK.

Background

Alvotech and Advanz Pharma have secured marketing authorisations from the European Commission for Gobivaz, the first approved biosimilar to Simponi (golimumab) across the European Economic Area. The companies said the approval marks a major step in efforts to expand access to biologic medicines used in the treatment of immune-mediated conditions.

Gobivaz will be available in 50 mg/0.5 mL and 100 mg/mL doses, offered in both pre-filled syringes with passive needle safety guards and autoinjectors. The treatment is approved for adults living with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis. It is also authorised for children aged two and above with juvenile idiopathic arthritis, when used together with methotrexate.

The approval is based on a total body of evidence, including positive clinical data and pharmacokinetic studies that confirmed similarity to the reference medicine.

Robert Wessman, Chairman and CEO of Alvotech, said the authorisation strengthens the company’s position in Europe and supports its mission to improve access to high-quality biologics. “As the first biosimilar to Simponi to gain approval in the European market, we are committed to expanding access for people living with immune-mediated diseases while providing value to healthcare systems,” he said.

Steffen Wagner, CEO of Advanz Pharma, said expanding access to biosimilars remains central to the company’s goals. He added that the approval gives patients across Europe a new treatment choice.

Under their agreement, Alvotech manages product development and supply, while Advanz Pharma holds exclusive commercial rights in the EEA and UK.