UK MHRA Accepts Application for Proposed Biosimilar to Xolair®
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Kashiv BioSciences LLC and ADVANZ PHARMA have announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted the marketing authorization application for AVT23, a proposed biosimilar to Xolair® (omalizumab).
Xolair® is a well-known biologic treatment used for severe allergic asthma and chronic rhinosinusitis with nasal polyps. With global sales expected to reach around USD $4.4 billion in 2024, the acceptance of this application marks a significant milestone.
AVT23 aims to offer a similar treatment to Xolair®, helping increase patient access to this important biologic. The partners, Alvotech and Advanz Pharma, have entered into a collaboration to bring AVT23 to market, which could help many more patients around the world.
What is AVT23?
AVT23 is a proposed biosimilar to Xolair® (omalizumab), a monoclonal antibody designed to target free immunoglobulin E (IgE). It’s primarily used to treat severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). AVT23 is still an investigational product and has not yet received regulatory approval.