Amneal Pharmaceuticals Files Biologics License Application for Xolair Biosimilar

MT Newswires Live

2025/09/26

Amneal Pharmaceuticals (AMRX) said Friday it submitted a biologics license application for a proposed biosimilar to Kashiv BioSciences-developed Xolair, a registered trademark of Novartis (NVS), with the US Food and Drug Administration.

Omalizumab, the generic name of Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria for a range of patient ages, Amneal said.

Amneal said it expects to incur a $22.5 million research and development milestone charge in Q3 rather than Q4. The company said it holds exclusive US commercialization rights for the product.

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

熱議股票

{"basename":"/hant","ssrTDKData":{"titleTemplate":"%s - 老虎證券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎證券,老虎證券開戶,老虎券商,老虎證券官網,老虎證券app,tigertrade老虎證券,股票,炒股,新加坡股票交易平臺,投資,投資理財","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hant/news/2570917885"},"companyName":"老虎證券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2570917885\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2570917885?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-09-26 20:34","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2570917885","market":"sh","top_or_hot":-1,"title":"Amneal Pharmaceuticals Files Biologics License Application for Xolair Biosimilar","media":"MT Newswires Live","content":"<html><body><p> Amneal Pharmaceuticals (AMRX) said Friday it submitted a biologics license application for a proposed biosimilar to Kashiv BioSciences-developed Xolair, a registered trademark of Novartis (NVS), with the US Food and Drug Administration.</p><p>Omalizumab, the generic name of Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria for a range of patient ages, Amneal said.</p><p>Amneal said it expects to incur a $22.5 million research and development milestone charge in Q3 rather than Q4. The company said it holds exclusive US commercialization rights for the product.</p></body></html>","source":"mtnewswires_news","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Amneal Pharmaceuticals Files Biologics License Application for Xolair Biosimilar</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nAmneal Pharmaceuticals Files Biologics License Application for Xolair Biosimilar\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time smaller\">2025-09-26 20:34</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html><body><p> Amneal Pharmaceuticals (AMRX) said Friday it submitted a biologics license application for a proposed biosimilar to Kashiv BioSciences-developed Xolair, a registered trademark of Novartis (NVS), with the US Food and Drug Administration.</p><p>Omalizumab, the generic name of Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria for a range of patient ages, Amneal said.</p><p>Amneal said it expects to incur a $22.5 million research and development milestone charge in Q3 rather than Q4. The company said it holds exclusive US commercialization rights for the product.</p></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0070302665.USD","symbol_name":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) ACC","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2570917885","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2570917885","pubTimestamp":1758890089,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Amneal Pharmaceuticals (AMRX) said Friday it submitted a biologics license application for a proposed biosimilar to Kashiv BioSciences-developed Xolair, a registered trademark of Novartis (NVS), with ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0070302665.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) ACC","LU0211331839.USD":"FRANKLIN MUTUAL GLB DISCOVERY \"A\" (USD) ACC","BK4588":"碎股","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","BK4578":"CAR-T","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","BK4585":"ETF&股票定投概念","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","BK4532":"文艺复兴科技持仓","LU0320765489.SGD":"FTIF - Franklin Mutual US Value A Acc SGD","NVS":"诺华","AMRX":"Amneal Pharmaceuticals, Inc.","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","BK4007":"制药","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU0208291251.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) INC"},"translate_title":"Amneal Pharmaceuticals提交Xolair生物仿制药的生物制剂许可申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NVS":1,"AMRX":1},"content_text":"Amneal Pharmaceuticals (AMRX) said Friday it submitted a biologics license application for a proposed biosimilar to Kashiv BioSciences-developed Xolair, a registered trademark of Novartis (NVS), with the US Food and Drug Administration.Omalizumab, the generic name of Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria for a range of patient ages, Amneal said.Amneal said it expects to incur a $22.5 million research and development milestone charge in Q3 rather than Q4. The company said it holds exclusive US commercialization rights for the product.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}