Alvotech: UK Agency OKs Marketing Authorization Application for Proposed Biosimilar to Xolair

 Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were about USD $4.4 billion 

https://www.globenewswire.com/news-release/2025/03/26/3049368/0/en/UK-Medicines-and-Healthcare-Products-Regulatory-Agency-Confirms-Acceptance-of-Marketing-Authorization-Application-for-Proposed-Biosimilar-to-Xolair-omalizumab.html