{"id":67519,"date":"2024-12-13T09:00:07","date_gmt":"2024-12-13T08:00:07","guid":{"rendered":"https:\/\/dorogimedence.hu\/?p=67519"},"modified":"2024-12-13T09:00:07","modified_gmt":"2024-12-13T08:00:07","slug":"az-fda-befogadta-a-richter-es-a-hikma-kozos-bioszimilaris-kerelmet","status":"publish","type":"post","link":"https:\/\/dorogimedence.hu\/index.php\/2024\/12\/13\/az-fda-befogadta-a-richter-es-a-hikma-kozos-bioszimilaris-kerelmet\/","title":{"rendered":"Az FDA befogadta a Richter \u00e9s a Hikma k\u00f6z\u00f6s bioszimil\u00e1ris k\u00e9relm\u00e9t"},"content":{"rendered":"<p><strong>A Richter Gedeon \u00e9s a Hikma Pharmaceuticals PLC bejelentette, hogy az FDA elfogadta bioszimil\u00e1ris k\u00e9sz\u00edtm\u00e9ny\u00fck enged\u00e9lyeztet\u00e9si k\u00e9relm\u00e9t. Az \u00faj fejleszt\u00e9s egy hum\u00e1n monoklon\u00e1lis antitesten alapul\u00f3 innov\u00e1ci\u00f3, amely csontritkul\u00e1s \u00e9s csont\u00e1tt\u00e9tek okozta t\u00f6r\u00e9sek kezel\u00e9s\u00e9re szolg\u00e1l.<\/strong><\/p>\n<p>A 2021-ben k\u00f6t\u00f6tt kiz\u00e1r\u00f3lagos \u00e9rt\u00e9kes\u00edt\u00e9si \u00e9s licenc meg\u00e1llapod\u00e1s szerint a Richter felel a k\u00e9sz\u00edtm\u00e9ny fejleszt\u00e9s\u00e9\u00e9rt, bele\u00e9rtve a glob\u00e1lis klinikai vizsg\u00e1latok lebonyol\u00edt\u00e1s\u00e1t \u00e9s a k\u00e9szterm\u00e9kek sz\u00e1ll\u00edt\u00e1s\u00e1t az USA piacra. A Hikma v\u00e9gzi az FDA-n\u00e1l t\u00f6rt\u00e9n\u0151 enged\u00e9lyeztet\u00e9st, \u00e9s kiz\u00e1r\u00f3lagos joggal forgalmazza majd a term\u00e9ket az Egyes\u00fclt \u00c1llamok piac\u00e1n a sz\u00fcks\u00e9ges j\u00f3v\u00e1hagy\u00e1sokat k\u00f6vet\u0151en.<\/p>\n<p>Ez a m\u00e9rf\u00f6ldk\u0151 meger\u0151s\u00edti a Richter elk\u00f6telez\u0151d\u00e9s\u00e9t a glob\u00e1lis bioszimil\u00e1ris programok fejleszt\u00e9se ir\u00e1nt, k\u00fcl\u00f6n\u00f6s tekintettel az Egyes\u00fclt \u00c1llamokra, \u00e9s a Hikma c\u00e9lkit\u0171z\u00e9s\u00e9t, hogy el\u00e9rhet\u0151bb\u00e9 tegye a nagy \u00e9rt\u00e9k\u0171 injekci\u00f3s gy\u00f3gyszereket az amerikai betegek sz\u00e1m\u00e1ra.<\/p>\n<p>Tov\u00e1bbi r\u00e9szletek <a href=\"https:\/\/www.gedeonrichter.com\/-\/media\/sites\/hq\/documents\/investors\/announcements\/2024\/20241212_bus_bio_reg_hikma_denosumab\/denosumab_fdasubmission_dec2024_hun.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline; color: #0000ff;\">ide kattintva<\/span><\/a> olvashat\u00f3k!<\/p>\n<p><em>Forr\u00e1s: Richter Gedeon Nyrt.<br \/>\nBor\u00edt\u00f3k\u00e9p: richter.hu (Ricther Gedeon Nyrt. \u00faj sz\u00e9kh\u00e1za K\u0151b\u00e1ny\u00e1n)<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Richter Gedeon \u00e9s a Hikma Pharmaceuticals PLC bejelentette, hogy az FDA elfogadta bioszimil\u00e1ris k\u00e9sz\u00edtm\u00e9ny\u00fck enged\u00e9lyeztet\u00e9si k\u00e9relm\u00e9t. Az \u00faj fejleszt\u00e9s egy hum\u00e1n monoklon\u00e1lis antitesten alapul\u00f3 innov\u00e1ci\u00f3, amely csontritkul\u00e1s \u00e9s csont\u00e1tt\u00e9tek okozta t\u00f6r\u00e9sek kezel\u00e9s\u00e9re szolg\u00e1l. A 2021-ben k\u00f6t\u00f6tt kiz\u00e1r\u00f3lagos \u00e9rt\u00e9kes\u00edt\u00e9si \u00e9s licenc meg\u00e1llapod\u00e1s szerint a Richter felel a k\u00e9sz\u00edtm\u00e9ny fejleszt\u00e9s\u00e9\u00e9rt, bele\u00e9rtve a glob\u00e1lis klinikai vizsg\u00e1latok lebonyol\u00edt\u00e1s\u00e1t<\/p>\n","protected":false},"author":1,"featured_media":67520,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[6934,3],"tags":[4060],"class_list":{"0":"post-67519","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-belfold","8":"category-hirek","9":"tag-richter"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Az FDA befogadta a Richter \u00e9s a Hikma k\u00f6z\u00f6s bioszimil\u00e1ris k\u00e9relm\u00e9t<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/dorogimedence.hu\/index.php\/2024\/12\/13\/az-fda-befogadta-a-richter-es-a-hikma-kozos-bioszimilaris-kerelmet\/\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:locale\" content=\"hu_HU\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:type\" content=\"article\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:title\" content=\"Az FDA befogadta a Richter \u00e9s a Hikma k\u00f6z\u00f6s bioszimil\u00e1ris k\u00e9relm\u00e9t\" class=\"yoast-seo-meta-tag\" \/>\n<meta property=\"og:description\" content=\"A Richter Gedeon \u00e9s a Hikma Pharmaceuticals PLC bejelentette, hogy az FDA elfogadta bioszimil\u00e1ris k\u00e9sz\u00edtm\u00e9ny\u00fck enged\u00e9lyeztet\u00e9si k\u00e9relm\u00e9t. 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