EMA Panel Backs Gobivaz®, Alvotech’s Golimumab Biosimilar, For Multiple Inflammatory Diseases

Alvotech and Advanz Pharma announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab).

"We look forward to working with Advanz Pharma to increase access for patients and healthcare professionals to golimumab, as the reference biologic Simponi® is an important treatment option for a number of immune-mediated diseases,” said Joseph McClellan, Chief Scientific and Technical Officer for Alvotech.

The recommendation covers Gobivaz® 50 mg/0.5 mL and 100 mg/mL in both pre-filled syringe and autoinjector presentations. The biosimilar is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis in adults, and juvenile idiopathic arthritis, across all 27 EU member states, as well as Norway, Iceland, and Liechtenstein.

A final European Commission decision is pending. If approved, Gobivaz® would expand access to a cost-effective alternative for patients requiring golimumab therapy. Under the partnership, Alvotech leads the development and commercial supply of Gobivaz®, while Advanz Pharma holds exclusive commercialization rights in Europe.

“The positive CHMP opinion for Gobivaz® is an important milestone in expanding patient access and marks a significant step forward in Advanz Pharma’s ambition to build a leading biosimilars presence in Europe,” said Nick Warwick, Chief Medical Officer, Advanz Pharma.

The positive CHMP opinion follows encouraging data from Alvotech’s clinical program. In April 2024, a confirmatory study in patients with moderate to severe rheumatoid arthritis demonstrated comparable efficacy, safety, and immunogenicity between Gobivaz® (AVT05) and the reference product Simponi®. Earlier, in November 2023, a pharmacokinetic study also confirmed similarity in PK profile, safety, and tolerability in healthy volunteers.