UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab)
Portfolio Pulse from
Alvotech, in partnership with Kashiv Biosciences and Advanz Pharma, has submitted a marketing authorization application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for AVT23, a proposed biosimilar to Xolair. The biosimilar targets severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps, with global Xolair sales reaching $4.4 billion in 2024.
March 26, 2025 | 8:45 am
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
MHRA's acceptance of AVT23 marketing application represents a significant step for Alvotech in expanding its biosimilar portfolio and potentially capturing market share in the Xolair segment.
The successful marketing authorization application demonstrates Alvotech's progress in developing competitive biosimilar products, which could positively impact investor sentiment and future revenue potential.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100