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

Core Insights - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), which is used for treating severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [1][4] - Global sales of Xolair in 2024 were approximately USD $4.4 billion, indicating a significant market opportunity for AVT23 [1] 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 [7] - Kashiv Biosciences is a fully integrated biopharmaceutical company dedicated to developing high-quality, cost-effective therapies, reflecting a commitment to innovation and improving access to biosimilars [3] - Advanz Pharma focuses on specialty, hospital, and rare disease medications, emphasizing the expansion of treatment options for patients [4] 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, further solidifying their collaboration in the biosimilar market [4]