{"id":176945,"date":"2025-12-05T17:47:08","date_gmt":"2025-12-05T17:47:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/176945\/"},"modified":"2025-12-05T17:47:08","modified_gmt":"2025-12-05T17:47:08","slug":"regulatory-reform-can-unlock-access-to-biosimilars","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/176945\/","title":{"rendered":"Regulatory reform can unlock access to biosimilars"},"content":{"rendered":"<p>Every day, I think about the patients waiting for medicines that could change, or even save, their lives. For them, access is not a statistic. It is hope, health, and a chance for a better future.\u00a0<\/p>\n<p>Biologic medicines have transformed treatment for <a href=\"https:\/\/www.who.int\/news\/item\/13-02-2025-biosimilars--expanding-access-to-essential-biologic-therapies\" target=\"_blank\" rel=\"noopener nofollow\">conditions like cancer and autoimmune diseases<\/a>. But the complexity of developing and manufacturing them, coupled with current market and regulatory dynamics, has driven costs up and put them out of reach for far too many patients.\u00a0<\/p>\n<p>Biosimilars offer a more affordable alternative and have <a href=\"https:\/\/www.iqvia.com\/-\/media\/iqvia\/pdfs\/library\/white-papers\/the-impact-of-biosimilar-competition-in-europe-2024.pdf\" target=\"_blank\" rel=\"noopener nofollow\">improved the lives of millions of patients<\/a> worldwide since their introduction almost 20 years ago. However, biosimilar medicine development currently takes six to nine years and costs between $100 million and $300 million <a href=\"https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/three-imperatives-for-r-and-d-in-biosimilars\" target=\"_blank\" rel=\"noopener nofollow\">per candidate<\/a>. At the same time, a \u201cbiosimilar void\u201d has emerged, where many biologic medicines that have lost (or are due to lose) patent protection do not have a biosimilar medicine candidate in development.<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.newsbeep.com\/ie\/wp-content\/uploads\/2025\/10\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" rel=\"nofollow noopener\" target=\"_blank\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 plus in-depth analysis, newsletters, premium events, and news alerts.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" rel=\"nofollow noopener\" target=\"_blank\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" rel=\"nofollow noopener\" target=\"_blank\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Every day, I think about the patients waiting for medicines that could change, or even save, their lives.&hellip;\n","protected":false},"author":2,"featured_media":176946,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[82674,1689,103,61,60,371,3667,2369],"class_list":{"0":"post-176945","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-biosimilars","9":"tag-fda","10":"tag-health","11":"tag-ie","12":"tag-ireland","13":"tag-medication","14":"tag-policy","15":"tag-stat"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/176945","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=176945"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/176945\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/176946"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=176945"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=176945"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=176945"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}