Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, 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 authorisations cover Gobivaz^® 50 mg/0.5 mL and 100 mg/mL presentations in both pre-filled syringe and autoinjector formats, for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis. The approvals apply across the United Kingdom.

”This approval further validates the strength and capabilities of Alvotech’s integrated development and manufacturing platform for biosimilars. We look forward to increasing access to an important biologic for the treatment of various immune-mediated diseases by making Gobivaz^® available to patients in collaboration with our partner Advanz Pharma,” said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.

“With these approvals, we are now well positioned to make Gobivaz^® available to patients and healthcare professionals in the UK, helping to broaden access to an important biologic treatment for immune-mediated diseases,” said Nick Warwick, Chief Medical Officer at Advanz Pharma.

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 partnership between Alvotech and Advanz Pharma, Alvotech is responsible for the development and commercial supply of Gobivaz^®, while Advanz Pharma holds the registration and exclusive commercialisation rights in Europe and the UK.