Alvotech (ALVO), on Wednesday announced that the UK Medicines and Healthcare Products Regulatory Agency OR MHRA has accepted the marketing authorization application for AVT23, a proposed biosimilar to Xolair Or omalizumab, a biologic used to treat severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps.
This acceptance follows the submission of the marketing application for AVT23, which Alvotech is developing in collaboration with Kashiv Biosciences and Advanz Pharma.
The marketing authorization application for AVT23 marks an important step forward in providing patients with greater access to this critical biologic therapy.
AVT23 is an investigational product, and biosimilarity has not yet been established by regulatory authorities. The biosimilar is currently under review, and no regulatory approval has been granted yet.
Alvotech, along with its partners, is advancing AVT23 with the goal of increasing patient access to high-quality, cost-effective treatments for conditions like allergic asthma and chronic rhinosinusitis.
Currently, ALVO is trading at $11.63 down by 0.26 percent on the Nasdaq.
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