Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use has adopted a positive opinion recommending approval for Gobivaz, Alvotech’s proposed biosimilar to Simponi, a biologic used to treat several chronic inflammatory diseases.
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“We look forward to working with Advanz Pharma to increase access for patients and healthcare professionals to golimumab, as the reference biologic Simponi is an important treatment option for a number of immune-mediated diseases,” said Joseph McClellan, Chief Scientific and Technical Officer for Alvotech.
“The positive CHMP opinion for Gobivaz is an important milestone in expanding patient access and marks a significant step forward in Advanz Pharma’s ambition to build a leading biosimilars presence in Europe.” said Nick Warwick, Chief Medical Officer, Advanz Pharma.
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The CHMP opinion recommends granting of a marketing authorization for Gobivaz 50 mg/0.5mL and 100mg/mL in a pre-filled syringe and autoinjector, for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adult patients and juvenile idiopathic arthritis across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.
Gobivaz remains under EMA regulatory review with a final decision by the European Commission pending.
Alvotech is responsible for the development and commercial supply of Gobivaz. Advanz Pharma is responsible for registration and has exclusive rights for commercialization in Europe.
In April 2024 Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between its biosimilar candidate AVT05 and Simponi (golimumab) in patients with moderate to severe rheumatoid arthritis. In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult participants.
About AVT05
AVT05 is a biosimilar candidate for Simponi (golimumab) and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
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Source- GlobeNewswire
