{"id":1497,"date":"2024-07-22T10:46:50","date_gmt":"2024-07-22T02:46:50","guid":{"rendered":"https:\/\/flcube.com\/?p=1497"},"modified":"2024-10-15T11:43:20","modified_gmt":"2024-10-15T03:43:20","slug":"bio-thera-solutions-submits-blas-for-stelara-biosimilar-bat2206-to-fda-and-ema","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=1497","title":{"rendered":"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA"},"content":{"rendered":"\n

Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ<\/a>) Stelara (ustekinumab), an auto-immune disease treatment.<\/p>\n\n\n\n

Stelara, the first all-human ‘dual-targeted’ inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23), has received five indication approvals in the US, covering a range of conditions including ulcerative colitis, Crohn\u2019s disease, active psoriatic arthritis, and psoriasis in addition to plaque psoriasis. The drug was first approved in China in 2017 and achieved sales of USD 10.858 billion for J&J in 2023.<\/p>\n\n\n\n

As Bio-Thera awaits regulatory decisions for its Stelara biosimilar in China, it has already secured commercialization partnerships for the drug in several key markets. The company has granted Hikma Pharmaceuticals USA Inc. rights for the US market, Biomm S.A. for Brazil, and Pharmapark LLC for Russia.- Flcube.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[65,289,43,150,149,38,858],"class_list":["post-1497","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-bio-thera-solutions","tag-biosimilars","tag-jj","tag-johnson-johnson","tag-market-approval-filings","tag-nyse-jnj"],"yoast_head":"\nBio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson's (J&J) Stelara (ustekinumab), an auto-immune disease treatment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=1497\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=1497\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-22T02:46:50+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-15T03:43:20+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=1497#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=1497\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA\",\"datePublished\":\"2024-07-22T02:46:50+00:00\",\"dateModified\":\"2024-10-15T03:43:20+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=1497\"},\"wordCount\":176,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Auto-immune\",\"Bio-Thera Solutions\",\"Biosimilars\",\"J&J\",\"Johnson & Johnson\",\"Market approval filings\",\"NYSE: JNJ\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=1497#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=1497\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=1497\",\"name\":\"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2024-07-22T02:46:50+00:00\",\"dateModified\":\"2024-10-15T03:43:20+00:00\",\"description\":\"Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson's (J&J) Stelara (ustekinumab), an auto-immune disease treatment.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=1497#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=1497\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=1497#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA - Insight, China's Pharmaceutical Industry","description":"Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson's (J&J) Stelara (ustekinumab), an auto-immune disease treatment.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=1497","og_locale":"en_US","og_type":"article","og_title":"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=1497","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-07-22T02:46:50+00:00","article_modified_time":"2024-10-15T03:43:20+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=1497#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=1497"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA","datePublished":"2024-07-22T02:46:50+00:00","dateModified":"2024-10-15T03:43:20+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=1497"},"wordCount":176,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Auto-immune","Bio-Thera Solutions","Biosimilars","J&J","Johnson & Johnson","Market approval filings","NYSE: JNJ"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=1497#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=1497","url":"https:\/\/flcube.com\/?p=1497","name":"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2024-07-22T02:46:50+00:00","dateModified":"2024-10-15T03:43:20+00:00","description":"Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson's (J&J) Stelara (ustekinumab), an auto-immune disease treatment.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=1497#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=1497"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=1497#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/1497","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1497"}],"version-history":[{"count":3,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/1497\/revisions"}],"predecessor-version":[{"id":6663,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/1497\/revisions\/6663"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1497"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1497"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1497"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}