Alvotech and Advanz Pharma Secure UK Approval for Gobivaz, a Biosimilar to Simponi

Alvotech and Advanz Pharma have announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations for all four presentations of Gobivaz, Alvotech’s biosimilar to Simponi (golimumab). The approvals mark a major step in expanding patient access to advanced biologic treatments for immune-mediated diseases in the United Kingdom.

The MHRA authorisations cover Gobivaz 50 mg/0.5 mL and 100 mg/mL formulations, available in both pre-filled syringe and autoinjector formats. The biosimilar is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis.

“This approval further validates the strength of Alvotech’s integrated biosimilar development and manufacturing platform,” said Joseph McClellan, Chief Scientific and Technical Officer at Alvotech. “We are pleased to collaborate with Advanz Pharma to make Gobivaz accessible to patients in need of effective treatments for immune-mediated diseases.”

Nick Warwick, Chief Medical Officer at Advanz Pharma, added, “With these approvals, we are now well positioned to make Gobivaz available to patients and healthcare professionals in the UK, broadening access to this important biologic therapy.”

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has also issued a positive opinion recommending Gobivaz for approval across the European Economic Area (EEA).

Under the partnership, Alvotech will handle the development and commercial supply of Gobivaz, while Advanz Pharma holds registration and exclusive commercialization rights in Europe and the UK.

The approval reinforces both companies’ commitment to improving biologic treatment accessibility and affordability for patients with chronic inflammatory conditions across the region.