{"id":153,"date":"2025-06-24T09:53:05","date_gmt":"2025-06-24T02:53:05","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/06\/24\/enam-biosimilars-bagian-dari-rekomendasi-otorisasi-ema-di-bulan-juni\/"},"modified":"2025-06-24T09:53:05","modified_gmt":"2025-06-24T02:53:05","slug":"enam-biosimilars-bagian-dari-rekomendasi-otorisasi-ema-di-bulan-juni","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/06\/24\/enam-biosimilars-bagian-dari-rekomendasi-otorisasi-ema-di-bulan-juni\/","title":{"rendered":"Enam Biosimilars Bagian dari Rekomendasi Otorisasi EMA di bulan Juni"},"content":{"rendered":"<div>\n<div class=\"\">\n<div style=\"width:30%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:\" class=\" figure\">\n<div id=\"image-caption\" class=\"text-gray-500 italic\">\n<div class=\"blockText_blockContent__TbCXh\">\n<p class=\"pb-2\">Tanda Teks Menampilkan Berita Industri. Teks foto bisnis menyampaikan berita kepada masyarakat umum atau target publik | Kredit Gambar: \u00a9 Artur &#8211; \u00a9 Artur &#8211; Stock.adobe.com<\/p>\n<\/div>\n<\/div>\n<div class=\"hidden top-(-100%) block w-(1px) transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden\"><img decoding=\"async\" class=\"m-auto absolute inset-0 max-w-(0%) max-h-(0%) border-(3px) border-solid border-white shadow-(0px_0px_8px_rgba(0,0,0,0.3)) box-border transition ease-in-out duration-500\" src=\"https:\/\/cdn.sanity.io\/images\/0vv8moc6\/pharmtech\/2b6495cc1c9eda73b83dc43c7e3fb48e6cf84ea8-1280x720.jpg?fit=crop&amp;auto=format\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"pb-2\">Komite Badan Obat Eropa untuk Produk Obat untuk Penggunaan Manusia (CHMP) merekomendasikan 13 obat untuk otorisasi pemasaran pada pertemuan 16-19 Juni (1). Di antara obat -obatan resmi adalah enam biosimilar dan dua obat generik. Persetujuan ini membawa total obat -obatan yang disetujui untuk otorisasi pada tahun 2025 sejauh ini hingga 56.<\/p>\n<p class=\"pb-2\">Austedo (deutetrabenazine) diberikan otorisasi pemasaran untuk perawatan orang dewasa dengan dyskinesia tardive sedang hingga berat. Pasien dengan tardive dyskinesia mengalami gerakan paksa abnormal yang dihasilkan dari paparan kronis atau episodik terhadap antagonis reseptor dopamin.<\/p>\n<p class=\"pb-2\">Pendapat positif diberikan kepada Imreplys (Sargramostim) untuk pengobatan sindrom radiasi akut hematopoietik, ketika sumsum tulang tidak menghasilkan cukup sel darah, yang menyebabkan infeksi dan pendarahan, setelah terpapar radiasi. Otorisasi diberikan dalam keadaan luar biasa, karena kelangkaan kondisi dan kurangnya data komprehensif (2).<\/p>\n<p class=\"pb-2\">Obat yatim, Ogsiveo (nirogacestat), disetujui untuk pengobatan orang dewasa dengan kemajuan tumor desmoid. Ini adalah tumor jaringan lunak yang terbentuk di jaringan berserat di daerah -daerah seperti perut, lengan, dan kaki, tetapi tidak menyebar ke lokasi lain.<\/p>\n<p class=\"pb-2\">Zemcelpro (sel -sel umbilikal dorocubicel\/yang tidak perlu diperluas) diberikan otorisasi pemasaran bersyarat untuk pengobatan orang dewasa dengan keganasan hematologis (kanker sel darah). Zemcelpro digunakan untuk mengobati pasien yang membutuhkan transplantasi sel induk hematopoietik alogenik setelah kemoterapi atau radioterapi ketika tidak ada jenis sel donor yang sesuai yang tersedia.<\/p>\n<p class=\"pb-2\">EMA juga memberikan otorisasi pemasaran bersyarat untuk rezdiffra (resmetirom) untuk mengobati orang dewasa dengan steatohepatitis terkait disfungsi metabolik nonkirotik. Tumbuk adalah suatu kondisi di mana sel -sel lemak menumpuk di hati dan menyebabkan peradangan kronis. Saat ini, tidak ada perawatan resmi untuk steatohepatitis terkait disfungsi metabolik di Uni Eropa.<\/p>\n<p class=\"pb-2\">Enam biosimilar berikut diberi pendapat positif pada pertemuan Juni:<\/p>\n<ul class=\"my-2\">\n<li class=\"list-disc ml-8\">Perawatan untuk pengobatan degenerasi makula dan gangguan penglihatan yang berhubungan dengan usia: mynzepli (aflibercept), dan duplikatnya Afiveg (Aflibercept), Vgenfli (Aflibercept), dan duplikat Eiyzey (Aflibercept)<\/li>\n<li class=\"list-disc ml-8\">USYMRO (Ustekinumab) Untuk pengobatan psoriasis plak, artritis psoriatik, dan penyakit Crohn<\/li>\n<li class=\"list-disc ml-8\">Vivlipeg (Pegfilgrastim) untuk mengurangi durasi neutropenia dan kejadian neutropenia demam setelah kemoterapi sitotoksik.<\/li>\n<\/ul>\n<p class=\"pb-2\">Dua obat generik juga disetujui. Emtricitabine\/rilpivirine\/Tenofovir alafenamide viatris (emtricitabine\/rilpivirine\/Tenofovir alafenamide) disetujui untuk mengobati orang dewasa dan remaja dengan pulkas nintedanib yang disetujui oleh HIV dengan kawan -kawan. Fenotip progresif, dan sklerosis sistemik yang terkait dengan penyakit paru interstitial.<\/p>\n<p class=\"pb-2\">CHMP juga memperluas indikasi untuk Benlysta, Cabometyx, Darzalex, Imbruvica, Nubeqa, dan Sarclisa. Indikasi untuk penggunaan cincin vagina dapivirine 25 mg (dapivirine) di luar UE dan oleh wanita berusia 16 tahun juga diperpanjang.<\/p>\n<p class=\"pb-2\">Selain itu, pada pertemuan tersebut, CHMP mengumumkan bahwa ia sedang memeriksa kembali pendapat negatifnya tentang Atropine Sulfate FGK (atropin), obat yang dimaksudkan untuk memperlambat perkembangan miopia pada anak -anak berusia 6 hingga 10 tahun dengan refraksi ekivalen bola dalam kisaran -0,50 hingga 6.00 Peri. Ini juga memeriksa kembali pendapat negatifnya tentang obat penyakit Alzheimer, Kisunla (Donanemab).<\/p>\n<h3 class=\"text-xl pb-4 pt-2\">Referensi<\/h3>\n<p class=\"pb-2\">1. EMA. Sorotan pertemuan dari Komite Produk Obat untuk Penggunaan Manusia (CHMP) 16\u201319 Juni 2025. Siaran Pers. 20 Juni 2025.<\/p>\n<p class=\"pb-2\">2. EMA. Keadaan luar biasa. Ema.europa.eu (diakses 23 Juni 2025). https:\/\/www.ema.europa.eu\/en\/glossary-terms\/exceptional-circumstances<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Tanda Teks Menampilkan Berita Industri. Teks foto bisnis menyampaikan berita kepada masyarakat umum atau target publik | Kredit Gambar: \u00a9 Artur &#8211; \u00a9 Artur &#8211; Stock.adobe.com Komite Badan Obat Eropa untuk Produk Obat untuk Penggunaan Manusia (CHMP) merekomendasikan 13 obat untuk otorisasi pemasaran pada pertemuan 16-19 Juni (1). Di antara obat -obatan resmi adalah enam [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":49,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-153","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Enam Biosimilars Bagian dari Rekomendasi Otorisasi EMA di bulan Juni - Nova Anggreni, S.Farm, APT<\/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:\/\/pythonsonline.com\/index.php\/2025\/06\/24\/enam-biosimilars-bagian-dari-rekomendasi-otorisasi-ema-di-bulan-juni\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Enam Biosimilars Bagian dari Rekomendasi Otorisasi EMA di bulan Juni - Nova Anggreni, S.Farm, APT\" \/>\n<meta property=\"og:description\" content=\"Tanda Teks Menampilkan Berita Industri. 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