Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Alvotech and Advanz Pharma have announced the receipt of marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for all four formulations of Gobivaz – Alvotech’s biosimilar to Simponi (golimumab).
The therapy is indicated for the treatment of rheumatoid arthritis and psoriatic arthritis. Credit: Towfiqu barbhuiya on Unsplash
Subscribe to our email newsletter
The authorisations are granted for Gobivaz in 50 mg/0.5 mL and 100 mg/mL formulations, available in pre-filled syringes and autoinjectors.
The medication is indicated for the treatment of psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, axial spondylarthritis and ulcerative colitis in adults throughout the UK.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favourable opinion recommending Gobivaz’s approval throughout the European Economic Area.
Under the collaboration, Alvotech is tasked with the development and commercial supply of Gobivaz, while Advanz Pharma possesses the exclusive rights for its commercialisation and registration in the UK and Europe.
Alvotech chief scientific and technical officer Joseph McClellan stated: “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.”
Advanz Pharma chief medical officer Nick Warwick stated: “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.”
Golimumab is a monoclonal antibody that targets and inhibits tumour necrosis factor alpha (TNF alpha).
Increased levels of TNF alpha have been implicated in chronic inflammatory conditions such as ankylosing spondylitis, rheumatoid arthritis and psoriatic arthritis.
