{"id":48084,"date":"2025-11-14T16:00:10","date_gmt":"2025-11-14T08:00:10","guid":{"rendered":"https:\/\/flcube.com\/?p=48084"},"modified":"2025-11-14T16:00:11","modified_gmt":"2025-11-14T08:00:11","slug":"gan-lees-ondibta-receives-positive-chmp-opinion-eu-biosimilar-pathway-opened","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48084","title":{"rendered":"Gan &amp;\u202fLee\u2019s Ondibta Receives Positive CHMP Opinion \u2013 EU Biosimilar Pathway Opened"},"content":{"rendered":"\n<p><strong>Gan &amp;\u202fLee Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/603087:SHA\">SHA: 603087<\/a>) announced that the <strong>European Medicines Agency (EMA)<\/strong> has issued a <strong>positive opinion<\/strong> from its Committee for Medicinal Products for Human Use (<strong>CHMP<\/strong>) on the company\u2019s <strong>Insulin Glargine Injection<\/strong>, marketed under the brand name <strong>Ondibta<\/strong>. The CHMP recommendation paves the way for the <strong>European Commission (EC)<\/strong> to grant a <strong>marketing authorization<\/strong> for Ondibta as a <strong>biosimilar<\/strong> to <strong>Sanofi\u2019s Lantus\u202fSoloStar<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-overview\">Product Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Product name<\/strong><\/td><td>Ondibta (Insulin Glargine Injection)<\/td><\/tr><tr><td><strong>Therapeutic class<\/strong><\/td><td>Basal, long\u2011acting insulin (GLP\u20111\u2011independent)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Diabetes mellitus (type\u202f1, type\u202f2, and pediatric \u2265\u202f2\u202fyears)<\/td><\/tr><tr><td><strong>Dosing<\/strong><\/td><td>Once\u2011daily subcutaneous injection; 24\u2011hour glucose\u2011lowering effect<\/td><\/tr><tr><td><strong>Key pharmacology<\/strong><\/td><td>Peak\u2011less, stable plasma concentration; smooth glucose control<\/td><\/tr><tr><td><strong>Biosimilarity<\/strong><\/td><td>Compared with Sanofi\u2019s Lantus\u202fSoloStar (EU reference)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context\">Market Context<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Sanofi\u2019s dominance:<\/strong> In 2024, Sanofi generated <strong>\u20ac2.855\u202fbn<\/strong> (\u2248\u202fUS$2.989\u202fbn) in global sales of its insulin glargine product, with <strong>\u20ac819\u202fm<\/strong> (\u2248\u202fUS$857\u202fm) coming from Europe.<\/li>\n\n\n\n<li><strong>European insulin market:<\/strong> Valued at <strong>\u2248\u202f\u20ac5\u202fbn<\/strong> in 2024, with biosimilars expected to capture <strong>10\u201115\u202f%<\/strong> of the market by 2028, driven by cost\u2011containment pressures and expanding pediatric use.<\/li>\n\n\n\n<li><strong>Pricing outlook:<\/strong> Early\u2011stage EU biosimilar pricing suggests a <strong>15\u201120\u202f% discount<\/strong> versus originator, potentially delivering <strong>\u20ac120\u2011150\u202fm<\/strong> in incremental revenue for Gan &amp;\u202fLee if a 5\u202f% market share is achieved.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestones\">Regulatory Milestones<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Date<\/th><th>Event<\/th><\/tr><\/thead><tbody><tr><td><strong>14\u202fNov\u202f2025<\/strong><\/td><td>CHMP issues positive opinion on Ondibta (biosimilar to Lantus\u202fSoloStar)<\/td><\/tr><tr><td><strong>~\u202fDec\u202f2025\u2011Jan\u202f2026<\/strong><\/td><td>Expected EC decision on marketing authorization<\/td><\/tr><tr><td><strong>Q2\u202f2026<\/strong><\/td><td>Anticipated commercial launch in EU member states (subject to EC approval)<\/td><\/tr><tr><td><strong>2027\u20112028<\/strong><\/td><td>Planned rollout in additional markets (UK, Canada, Japan) under separate regulatory pathways<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Diversification of revenue:<\/strong> Ondibta adds a <strong>non\u2011Chinese, high\u2011margin biosimilar<\/strong> to Gan &amp;\u202fLee\u2019s pipeline, reducing reliance on domestic oncology assets.<\/li>\n\n\n\n<li><strong>Global footprint:<\/strong> Successful EU approval will give Gan &amp;\u202fLee a foothold in the <strong>regulated Western insulin market<\/strong>, facilitating future <strong>cross\u2011border partnerships<\/strong>.<\/li>\n\n\n\n<li><strong>Cost\u2011advantage positioning:<\/strong> As a biosimilar, Ondibta can be priced competitively, appealing to <strong>national health services<\/strong> and <strong>private insurers<\/strong> seeking lower\u2011cost basal insulin options.<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding the timing of regulatory approvals, market entry, and revenue expectations for Ondibta. Actual results may differ due to regulatory outcomes, competitive actions, pricing negotiations, and other risks disclosed in Gan &amp;\u202fLee\u2019s most recent annual report and filings.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gan &amp;\u202fLee Pharmaceuticals Co., Ltd. (SHA: 603087) announced that the European Medicines Agency (EMA) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48102,"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":[39,421,15,147,1120],"class_list":["post-48084","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-diabetes","tag-gan-lee-pharmaceuticals","tag-product-approvals","tag-sanofi","tag-sha-603087"],"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>Gan &amp;\u202fLee\u2019s Ondibta Receives Positive CHMP Opinion \u2013 EU Biosimilar Pathway Opened - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Gan &amp;\u202fLee Pharmaceuticals Co., Ltd. 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(SHA: 603087) announced that the European Medicines Agency (EMA) has issued a positive opinion from its Committee for Medicinal Products for Human Use (CHMP) on the company\u2019s Insulin Glargine Injection, marketed under the brand name Ondibta. 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(SHA: 603087) announced that the European Medicines Agency (EMA) has issued a positive opinion from its Committee for Medicinal Products for Human Use (CHMP) on the company\u2019s Insulin Glargine Injection, marketed under the brand name Ondibta. The CHMP recommendation paves the way for the European Commission (EC) to grant a marketing authorization for Ondibta as a biosimilar to Sanofi\u2019s Lantus\u202fSoloStar.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=48084#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=48084"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=48084#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1305-1.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1305-1.webp","width":1080,"height":608,"caption":"Gan &\u202fLee\u2019s Ondibta Receives Positive CHMP Opinion \u2013 EU Biosimilar Pathway Opened"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=48084#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Gan &amp;\u202fLee\u2019s Ondibta Receives Positive CHMP Opinion \u2013 EU Biosimilar Pathway Opened"}]},{"@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":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1305-1.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48084","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=48084"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48084\/revisions"}],"predecessor-version":[{"id":48105,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48084\/revisions\/48105"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/48102"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=48084"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=48084"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=48084"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}