Alvotech SA and Partners Announce Positive Regulatory Review for Xolair® Biosimilar AVT23, with Marketing Authorization Application Validated by UK MHRA

Reuters

06/25

<a href="https://laohu8.com/S/ALVO">Alvotech</a> SA and Partners Announce Positive Regulatory Review for Xolair® Biosimilar AVT23, with Marketing Authorization Application Validated by UK MHRA

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alvotech SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001114574-en) on June 25, 2025, and is solely responsible for the information contained therein.

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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 <a href=\"https://laohu8.com/S/EMA\">$(EMA)$</a> by the end of the year, showcasing their commitment to expanding access to specialty medicines across Europe, Canada, and Australia.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alvotech SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001114574-en) on June 25, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B64PRP62.GBP","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250625:nNDLc2N8jd:1","article_id":"2546995602","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2546995602","pubTimestamp":1750838415,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Alvotech SA and Partners Announce Positive Regulatory Review for Xolair Biosimilar AVT23, with Marketing Authorization Application Validated by UK MHRA. 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