Posted by Michael Wonder on 29 Sep 2025
EMA recommends marketing approval of Gobivaz, Alvotech’s proposed biosimilar to Simponi (golimumab) with Advanz Pharma as commercialisation partner
22 September 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP has adopted a positive opinion recommending approval for Gobivaz, Alvotech’s proposed biosimilar to Simponi (golimumab), a biologic used to treat several chronic inflammatory diseases.
The CHMP opinion recommends granting of a marketing authorisation for Gobivaz 50 mg/0.5 mL and 100 mg/mL in a pre-filled syringe and auto-injector, for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adult patients and juvenile idiopathic arthritis across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.
