Alvotech's Xolair Biosimilar AVT23 Achieves Positive Phase III Results and UK Regulatory Acceptance
Key Insights
Alvotech, Kashiv Biosciences (search), and Advanz Pharma (search) announced positive topline results from a confirmatory efficacy study of AVT23, a proposed biosimilar to Xolair (omalizumab), demonstrating therapeutic equivalence and comparable safety in chronic spontaneous urticaria patients.
The randomized, double-blind study enrolled 600 patients and met its primary endpoint of change from baseline in weekly Itch Severity Score at Week 12, with 400 patients receiving the confirmatory 300 mg dose evaluated for efficacy and safety.
The UK Medicines and Healthcare Products Regulatory Agency has accepted the marketing authorization application for AVT23, targeting a market where Xolair generated approximately $4.4 billion in global sales in 2024.
Alvotech, Kashiv Biosciences (search), and Advanz Pharma (search) have achieved a significant regulatory and clinical milestone with their proposed biosimilar to Xolair (omalizumab), reporting positive results from a confirmatory efficacy study and regulatory acceptance in the UK for AVT23. The development targets a substantial market opportunity, with Xolair generating approximately $4.4 billion in global sales in 2024.
Clinical Study Demonstrates Therapeutic Equivalence
The randomized, double-blind, multicenter study evaluated AVT23 compared to the reference biologic Xolair in patients with Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines. The study successfully met its primary endpoint, demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic.
A total of 600 patients were enrolled in the study, with efficacy and safety evaluated in 400 patients who received the confirmatory dose of 300 mg. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks over a 24-week period. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12 between the treatment groups of AVT23 and the reference product.
"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," said Joseph McClellan, Chief Scientific Officer of Alvotech.
Regulatory Progress Across Key Markets
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for AVT23, marking a crucial regulatory milestone. The companies expect to file a marketing authorization application with the European Medicines Agency (EMA) before the end of the year.
Dr. Nick Warwick, Chief Medical Officer of Advanz Pharma (search), stated, "This achievement marks a significant step in expanding treatment options for patients and reinforces Advanz Pharma's dedication to enhancing access to specialty, hospital, and rare disease medications."
Therapeutic Profile and Market Potential
AVT23 is designed as a biosimilar to Xolair (omalizumab), a humanized monoclonal antibody that targets free immunoglobulin E (IgE). The reference product is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy. The biosimilar candidate represents an opportunity to increase patient access to this important biologic therapy through cost-effective alternatives.
"This marks a positive advancement for Kashiv's growing biosimilar pipeline in addition to its current portfolio of Releuko and Fylnetra. We look forward to collaborating with regulatory authorities to make this treatment available to patients," said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences (search).
Strategic Partnership Framework
The development of AVT23 involves a collaborative partnership structure established through multiple agreements. Alvotech and Advanz Pharma (search) entered into a commercialization agreement for AVT23 in February 2023, later expanding their strategic partnership in May 2023 to include five additional biosimilar candidates under development by Alvotech. Alvotech and Kashiv announced their licensing agreement for AVT23 in October 2023.
"At Kashiv, we are committed to developing high-quality, cost-effective therapies. The successful acceptance by MHRA of the marketing authorization for AVT23 reflects our dedication to innovation and improving access to vital biosimilars on a global scale," said Chirag and Chintu Patel, Executive Chairman and Co-Founders of Kashiv Biosciences (search).
The successful confirmatory efficacy results and regulatory acceptance position AVT23 as a potential biosimilar option for patients requiring omalizumab therapy, with the companies working toward broader global regulatory approvals and eventual market access.