Alvotech and Advanz Pharma Win UK Approval for Simponi Biosimilar Gobivaz
Reuters
Nov 06, 2025
Alvotech and Advanz Pharma Win UK Approval for Simponi Biosimilar Gobivaz
Alvotech SA and Advanz Pharma have received marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Gobivaz®, a biosimilar to Simponi® (golimumab). The approvals cover all four presentations of Gobivaz®-50 mg/0.5 mL and 100 mg/mL in both pre-filled syringe and autoinjector formats-for the treatment of several immune-mediated diseases, including rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis. Additionally, the European Medicines Agency's Committee for Medicinal Products for Human Use $(CHMP)$ has issued a positive opinion recommending approval of Gobivaz® across the European Economic Area. Under their partnership, Alvotech is responsible for development and supply, while Advanz Pharma manages registration and commercialisation in Europe and the UK.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alvotech SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001137395-en) on November 06, 2025, and is solely responsible for the information contained therein.
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