{"id":34203,"date":"2025-05-27T12:15:08","date_gmt":"2025-05-27T04:15:08","guid":{"rendered":"https:\/\/flcube.com\/?p=34203"},"modified":"2025-05-27T12:15:08","modified_gmt":"2025-05-27T04:15:08","slug":"bio-thera-solutions-bat2206-biosimilar-of-stelara-gains-fda-approval","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=34203","title":{"rendered":"Bio-Thera Solutions&#8217; BAT2206 Biosimilar of Stelara Gains FDA Approval"},"content":{"rendered":"\n<p>Guangzhou-based Bio-Thera Solutions Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/688177:SHA\">SHA: 688177<\/a>) announced that it has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for its BAT2206, a biosimilar of Johnson &amp; Johnson\u2019s (J&amp;J) Stelara (ustekinumab). The approval allows the drug, marketed as Starjemza, to be used for treating adult patients with moderate to severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderate to severe active Crohn&#8217;s disease (CD), and moderate to severe active ulcerative colitis (UC). It is also approved for pediatric patients with moderate to severe PsO and active PsA.<\/p>\n\n\n\n<p><strong>Stelara and Its Mechanism<\/strong><br>Stelara is recognized as the world&#8217;s first all-human &#8220;dual-targeted&#8221; inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23). This mechanism of action makes it effective in treating various autoimmune conditions. Bio-Thera\u2019s biosimilar, Starjemza, is awaiting regulatory decisions in China and the European Union (EU).<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688177_20250524_QY26.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688177_20250524_QY26.\"><\/object><a id=\"wp-block-file--media-67a4af1f-15dd-441c-9bd2-2b9b0cb6132f\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688177_20250524_QY26.pdf\">688177_20250524_QY26<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688177_20250524_QY26.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-67a4af1f-15dd-441c-9bd2-2b9b0cb6132f\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Guangzhou-based Bio-Thera Solutions Ltd. (SHA: 688177) announced that it has received Biologic License Application (BLA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":34205,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[65,289,43,150,149,15,1055],"class_list":["post-34203","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-bio-thera-solutions","tag-biosimilars","tag-jj","tag-johnson-johnson","tag-product-approvals","tag-sha-688177"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bio-Thera Solutions&#039; BAT2206 Biosimilar of Stelara Gains FDA Approval - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Guangzhou-based Bio-Thera Solutions Ltd. (SHA: 688177) announced that it has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for its BAT2206, a biosimilar of Johnson &amp; Johnson\u2019s (J&amp;J) Stelara (ustekinumab). The approval allows the drug, marketed as Starjemza, to be used for treating adult patients with moderate to severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderate to severe active Crohn&#039;s disease (CD), and moderate to severe active ulcerative colitis (UC). It is also approved for pediatric patients with moderate to severe PsO and active PsA.\" \/>\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=34203\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bio-Thera Solutions&#039; BAT2206 Biosimilar of Stelara Gains FDA Approval\" \/>\n<meta property=\"og:description\" content=\"Guangzhou-based Bio-Thera Solutions Ltd. (SHA: 688177) announced that it has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for its BAT2206, a biosimilar of Johnson &amp; Johnson\u2019s (J&amp;J) Stelara (ustekinumab). The approval allows the drug, marketed as Starjemza, to be used for treating adult patients with moderate to severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderate to severe active Crohn&#039;s disease (CD), and moderate to severe active ulcerative colitis (UC). 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