Alvotech SA, in collaboration with Kashiv Biosciences LLC and Advanz Pharma, has announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application $(MAA)$ for their proposed biosimilar, AVT23, to Xolair® (omalizumab). The positive outcome from their confirmatory efficacy study marks a significant step towards increasing patient access to this important medication for Chronic Spontaneous Urticaria (CSU). The consortium is planning to file an MAA with the European Medicines Agency $(EMA)$ by the end of the year, showcasing their commitment to expanding access to specialty medicines across Europe, Canada, and Australia.
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