Alvotech, Kashiv, and Advanz Pharma Secure MHRA Acceptance for Xolair® Biosimilar AVT23

Alvotech, Kashiv Biosciences, and Advanz Pharma have announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted the marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab). This milestone represents a crucial step toward expanding patient access to cost-effective biologics for severe allergic asthma and chronic rhinosinusitis with nasal polyps. In 2024, global sales of Xolair reached $4.4 billion, underscoring the significant demand for effective treatment options. Joseph McClellan, CSO of Alvotech, emphasized the importance of increasing accessibility to essential therapies, while Chirag and Chintu Patel, Co-Founders of Kashiv Biosciences, reaffirmed their commitment to innovation in biosimilars.

This development builds on strategic partnerships between Alvotech, Kashiv, and Advanz Pharma, which include licensing and commercialization agreements for multiple biosimilars. Dr. Nick Warwick, CMO of Advanz Pharma, highlighted the impact of this acceptance in expanding treatment options for patients. Alvotech and Advanz Pharma first entered into a commercialization agreement for AVT23 in 2023, later expanding the partnership to cover five additional biosimilars under development. As the regulatory review progresses, the approval of AVT23 has the potential to offer a more affordable alternative to Xolair, ensuring broader access to critical treatments for patients worldwide.