{"id":3432,"date":"2026-08-19T09:44:52","date_gmt":"2026-08-19T09:44:52","guid":{"rendered":"https:\/\/drsoniafawad.com\/?p=3432"},"modified":"2026-08-19T09:44:52","modified_gmt":"2026-08-19T09:44:52","slug":"fda-approves-two-autoinjector-formulations-for-stelara-biosimilar","status":"publish","type":"post","link":"https:\/\/drsoniafawad.com\/?p=3432","title":{"rendered":"FDA approves two autoinjector formulations for Stelara biosimilar"},"content":{"rendered":"<p><br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\" article__posted-date\">\n<p>August 19, 2026<\/p>\n<p>1 min read<\/p>\n<\/p><\/div>\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-5 d-xl-none\">\n<div class=\"trust-box\">\n<div class=\"trust-box-logo d-none d-md-block\">\n            <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/rheum.svg?la=en&amp;h=44&amp;w=141&amp;hash=EBAD778B57889935130139D3FF110538\" class=\"logo-img\" height=\"44\" alt=\"healio rheumatology logo\" width=\"141\"\/>\n          <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse uc99fd946ccef4567a9c9a138f4af1561\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact <a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20260818\/mailto:customerservice@slackinc.com\">customerservice@slackinc.com<\/a>.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<h2>Key takeaways:<\/h2>\n<ul>\n<li>The FDA has approved two autoinjector doses of the biosimilar ustekinumab-kfce.<\/li>\n<li>The biosimilar is indicated for psoriasis, psoriatic arthritis, Crohn\u2019s disease and ulcerative colitis.<\/li>\n<\/ul>\n<p>The FDA has approved a pair of prefilled autoinjector formulations for the <a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20241202\/fda-approves-yesintek-sixth-stelara-biosimilar-launch-slated-for-february\" id=\"rId10\" target=\"_blank\">Stelara biosimilar ustekinumab-kfce<\/a>, according to a press release from the manufacturer.<\/p>\n<p>Ustekinumab-kfce (Yesintek, Biocon Limited) will now be offered in a 45 mg\/0.5 ml single-dose prefilled autoinjector and a 90 mg\/ml single-dose prefilled autoinjector. The biosimilar is indicated for moderate to severe plaque psoriasis and active <a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20260727\/glp1s-for-diabetes-may-increase-risk-for-psoriatic-disease-vs-dpp4-inhibitors\" id=\"rId11\" target=\"_blank\">psoriatic arthritis<\/a> in adult and pediatric patients 6 years and older, as well as moderate to severely active Crohn\u2019s disease and ulcerative colitis in adults.<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.jpg?w=800\" alt=\"Generic FDA News infographic\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<br \/>\n      The FDA has approved a pair of prefilled autoinjector formulations for the Stelara biosimilar ustekinumab-kfce.&#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>\u201cThis new delivery format supports more tailored treatment approaches across different care settings and patient needs,\u201d read the statement from Biocon.<\/p>\n<p>The FDA initially approved Yesintek on Nov. 29, 2024, as the sixth biosimilar for Stelara (ustekinumab, Janssen). It later made its market debut in the United States in February 2025, <a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20250303\/first-four-stelara-biosimilars-launch-in-us-white-labeling-threatens-market-vibrancy\" id=\"rId12\" target=\"_blank\">following legal settlements<\/a> between Janssen and the various manufacturers of Stelara biosimilars, including Biocon.<\/p>\n<p>\u201cThis supplemental approval enhances Biocon\u2019s comprehensive portfolio of immunology products in the United States and reaffirms the company\u2019s commitment to improving access to affordable medicines for patients around the world,\u201d read the Biocon statement.<\/p>\n<div class=\"article__content--footer\">\n<div class=\"publisher-logo\">\n    <span>Published by:<\/span><br \/>\n    <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/rheum.svg?la=en&amp;h=44&amp;w=141&amp;hash=EBAD778B57889935130139D3FF110538\" class=\"logo-img\" height=\"44\" alt=\"healio rheumatology logo\" width=\"141\"\/>\n  <\/div>\n<div class=\"sources-references-disclosures\">\n<h3>Sources\/Disclosures<\/h3>\n<h2>Reference:<\/h2>\n<\/div>\n<p><!-- Healio AI Widget --><\/p>\n<div class=\"healio-ai-component-inline\" data-no-ads=\"true\" data-module-track-category=\"Healio AI\" data-module-track-action=\"Click\" data-module-track-label=\"Access Healio Ai from component - News_AI Component - In-Content (all devices)\">\n<div class=\"healio-ai-content\">\n    <img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/images\/healio-ai\/healio-ai_logo.svg\" alt=\"Healio AI\" class=\"healio-ai-logo\"\/><\/p>\n<p><strong>Ask a clinical question<\/strong> and tap into <strong>Healio AI&#8217;s knowledge<\/strong> base.<\/p>\n<ul>&#13;<\/p>\n<li>PubMed, enrolling\/recruiting trials, guidelines<\/li>\n<p>&#13;<\/p>\n<li>Clinical Guidance, Healio CME, FDA news<\/li>\n<p>&#13;<\/p>\n<li>Healio&#8217;s exclusive daily news coverage of clinical data<\/li>\n<p>&#13;\n    <\/ul>\n<p>    <button class=\"healio-ai-button\" onclick=\"window.location.href=\" https:=\"\">Learn more<\/button>\n  <\/div>\n<\/div>\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse uc99fd946ccef4567a9c9a138f4af1561\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact <a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20260818\/mailto:customerservice@slackinc.com\">customerservice@slackinc.com<\/a>.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20260818\/fda-approves-two-prefilled-autoinjector-formulations-for-stelara-biosimilar\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>August 19, 2026 1 min read &#13; &#13; &#13; Add topic to email alerts&#13; &#13; &#13; Receive an email when new articles are posted on &#13; Please provide your email address to receive an email when new articles are posted on . &#8220;&#13; data-action=&#8221;subscribe&#8221;&gt;&#13; Subscribe&#13; We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The FDA has approved two autoinjector doses of the biosimilar ustekinumab-kfce. The biosimilar is indicated for psoriasis, psoriatic arthritis, Crohn\u2019s disease and ulcerative colitis. The FDA has approved a pair of prefilled autoinjector formulations for the Stelara biosimilar ustekinumab-kfce, according to a press release from the manufacturer. Ustekinumab-kfce (Yesintek, Biocon Limited) will now be offered in a 45 mg\/0.5 ml single-dose prefilled autoinjector and a 90 mg\/ml single-dose prefilled autoinjector. The biosimilar is indicated for moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients 6 years and older, as well as moderate to severely active Crohn\u2019s disease and ulcerative colitis in adults. &#13; &#13;&#13;&#13;&#13;&#13;&#13; &#13; &#13; &#13;&#13; The FDA has approved a pair of prefilled autoinjector formulations for the Stelara biosimilar ustekinumab-kfce.&#13; &#13; \u201cThis new delivery format supports more tailored treatment approaches across different care settings and patient needs,\u201d read the statement from Biocon. The FDA initially approved Yesintek on Nov. 29, 2024, as the sixth biosimilar for Stelara (ustekinumab, Janssen). It later made its market debut in the United States in February 2025, following legal settlements between Janssen and the various manufacturers of Stelara biosimilars, including Biocon. \u201cThis supplemental approval enhances Biocon\u2019s comprehensive portfolio of immunology products in the United States and reaffirms the company\u2019s commitment to improving access to affordable medicines for patients around the world,\u201d read the Biocon statement. Published by: Sources\/Disclosures Reference: Ask a clinical question and tap into Healio AI&#8217;s knowledge base. &#13; PubMed, enrolling\/recruiting trials, guidelines &#13; Clinical Guidance, Healio CME, FDA news &#13; Healio&#8217;s exclusive daily news coverage of clinical data &#13; Learn more &#13; &#13; &#13; Add topic to email alerts&#13; &#13; &#13; Receive an email when new articles are posted on &#13; Please provide your email address to receive an email when new articles are posted on . &#8220;&#13; data-action=&#8221;subscribe&#8221;&gt;&#13; Subscribe&#13; We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. 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