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First biosimilar version of J&J’s Simponi approved in Europe

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Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.

Johnson & Johnson Simponi biosimilar

Alvotech’s Gobivaz biosimilar has been approved in Europe and once launched will offer competition to its originator product, Johnson & Johnson’s monoclonal antibody Simponi (golimumab).

The authorisation is for Gobivaz® 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats.

The European Commission approved indication covers adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and for juvenile idiopathic arthritis in children two years of age and over in combination with methotrexate.

Golimumab inhibits tumour necrosis factor alpha (TNF alpha), which is associated with several chronic inflammatory diseases such as rheumatoid arthritis.

The EC approval of Gobivaz was based on a variety of evidence including data from Alvotech’s phase I study. The company announced positive topline results in November 2023. The study compared the pharmacokinetics, safety, and tolerability of AVT05 (golimumab) to Simponi in healthy adults.

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”

Findings from a confirmatory clinical study, shared in April 2024, also formed part of the EC’s final assessment. The trial compared efficacy, safety, and immunogenicity between AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis.

The EC’s approval follows the Committee for Medicinal Products for Human Use (CHMP)’s positive opinion for Gobivaz in September.

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.”

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