Alvotech (ALVO), Kashiv Biosciences, and Advanz Pharma said Wednesday that an efficacy study comparing AVT23, a proposed biosimilar to Xolair, in patients with chronic spontaneous urticarial met its primary endpoint.
The study covered patients who remained symptomatic despite treatment with H1 antihistamines. The companies said the results showed "equivalence of therapeutic endpoints and comparable safety" between the biosimilar candidate and the reference biologic.
Xolair is a trademark of Novartis (NVS).
Alvotech, Kashiv and Advanz said the UK Medicines and Healthcare Products Regulatory Agency has already accepted the marketing authorization application for AVT23 earlier this year, while the filing of an application with the European Medicines Agency is expected before the end of the year.
Chronic spontaneous urticaria is a debilitating skin condition.
Alvotech shares were up 6.3% in recent premarket activity.
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