UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab)

Core Viewpoint - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair, which is significant for increasing patient access to biologic treatments for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [1][2][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates targeting various diseases [7]. - Kashiv Biosciences is a fully integrated biopharmaceutical company dedicated to developing high-quality, cost-effective therapies, reflecting a commitment to innovation and global access to biosimilars [3]. - Advanz Pharma is a UK-based pharmaceutical company focused on specialty, hospital, and rare disease medications, emphasizing the expansion of treatment options for patients [4]. Product Information - AVT23 is an investigational biosimilar to Xolair (omalizumab), which targets free immunoglobulin E (IgE) and is indicated for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [5]. - Global sales of Xolair were approximately USD 4.4 billion in 2024, highlighting the market potential for AVT23 [1]. Strategic Partnerships - Alvotech and Advanz Pharma entered a commercialization agreement for AVT23 in February 2023, which was later expanded to include five additional biosimilar candidates [4]. - Alvotech and Kashiv announced a licensing agreement for AVT23 in October 2023, indicating a collaborative approach to bringing biosimilars to market [4].