UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab)
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Alvotech, in partnership with Kashiv Biosciences and Advanz Pharma, has received marketing authorization application acceptance from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for AVT23, a proposed biosimilar to Xolair. This represents a significant step towards increasing patient access to a biologic treatment for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair were approximately $4.4 billion in 2024.
March 26, 2025 | 8:45 am
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POSITIVE IMPACT
MHRA's acceptance of AVT23's marketing application signals potential market expansion for Alvotech's biosimilar portfolio, demonstrating progress in their strategic development of cost-effective biologic alternatives.
The MHRA's acceptance represents a critical milestone in Alvotech's product development, potentially opening new market opportunities and validating their biosimilar approach.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100