A confirmatory efficacy study conducted by Alvotech, Kashiv Biosciences, and Advanz Pharma of AVT23, a proposed biosimilar to Xolair (omalizumab), has met its primary endpoint.
The study showed that AVT23 is therapeutically equivalent and has a comparable safety profile to the reference biologic in treating chronic spontaneous urticaria (CSU).
Participants in the randomised, double-blind, multicentre trial included patients who had not responded to H1 antihistamines.
The study’s results, which covered 24 weeks of treatment with subcutaneous doses of either 150 mg or 300 mg every four weeks, enrolled a total of 600 patients. Of these, 400 received the confirmatory dose of 300 mg.
The primary measure for efficacy focused on the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12 between the treatment groups.
Alvotech chief scientific officer Joseph McClellan said: “The positive results from this confirmatory patient study represent an important step in the development of the Xolair biosimilar candidate. We look forward to working with our partners to increase global patient access to this important medicine.”
Earlier this year, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) validated and accepted the marketing authorisation application for AVT23. An application submission is anticipated with the European Medicines Agency before year-end.
AVT23 aims to replicate Xolair’s effects, which contains omalizumab—a humanised monoclonal antibody targeting free immunoglobulin E (IgE), used in treatments for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Currently under investigation, AVT23 has neither received approval from any regulatory authorities nor has it been established as biosimilar.
Alvotech has collaborated with Kashiv BioSciences in developing the proposed Xolair biosimilar, known as AVT23 by the former and ADL-018 by the latter.
Advanz Pharma chief medical officer Nick Warwick said: “The successful confirmatory efficacy results for the proposed biosimilar to XOLAIR mark an important milestone in Advanz Pharma’s ambition to expand patient access to specialty medicines across our core geographies, Europe, Canada, and Australia.”
