<a href="https://laohu8.com/S/ALVO">Alvotech</a> and Advanz Pharma's Biosimilar to Xolair® (omalizumab), AVT23, Accepted for Regulatory Review by European Medicines Agency
**Alvotech SA and Advanz Pharma Announce EMA Acceptance of Marketing Application for AVT23, Proposed Biosimilar to Xolair®** LONDON and REYKJAVIK, Iceland, October 6, 2025 - Alvotech SA, in collaboration with Advanz Pharma and Kashiv BioSciences LLC, announced that the European Medicines Agency $(EMA)$ has accepted the Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair® (omalizumab). This milestone could expand patient access to affordable biologic treatments for severe asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps across Europe. Advanz Pharma holds commercial rights for AVT23 in the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand. The UK's MHRA had previously accepted a similar application earlier this year. No grant or funding announcement was made; the regulatory review is ongoing.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alvotech SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001131663-en) on October 06, 2025, and is solely responsible for the information contained therein.
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