Alvotech And Advanz Pharma Secure UK MHRA Marketing Authorisations For Gobivaz®, A Biosimilar Of Simponi® (golimumab)

Alvotech, a global biotechnology company dedicated to developing and manufacturing biosimilar medicines, and Advanz Pharma Holdco Limited, a UK-based global pharmaceutical company focused on specialty, hospital, and rare disease medicines in Europe, 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 MHRA approvals include Gobivaz® 50 mg/0.5 mL and 100 mg/mL in both pre-filled syringe and autoinjector formats. These authorisations cover the treatment of several immune-mediated conditions, including rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis, and apply throughout the United Kingdom.

Joseph McClellan, Chief Scientific and Technical Officer at Alvotech, stated that this milestone demonstrates the strength of Alvotech’s integrated development and manufacturing platform for biosimilars. He added that the company looks forward to expanding patient access to important biologic therapies for immune-mediated diseases through its collaboration with Advanz Pharma.

Nick Warwick, Chief Medical Officer at Advanz Pharma, emphasized that the MHRA approvals will enable the companies to make Gobivaz® available to patients and healthcare professionals across the UK. He noted that this will help improve access to effective biologic treatments for various immune-related conditions.

In addition to the UK approval, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Gobivaz® across the European Economic Area. Under the terms of their partnership, Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds the registration and exclusive commercialisation rights for the product in Europe and the UK.