{"id":4681,"date":"2018-10-29T15:55:09","date_gmt":"2018-10-29T15:55:09","guid":{"rendered":"https:\/\/blog.kolabtree.com\/?p=4681"},"modified":"2020-11-08T16:48:44","modified_gmt":"2020-11-08T16:48:44","slug":"biosimilars-benefits-challenges-and-future","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/","title":{"rendered":"\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3002\u5229\u70b9\u3001\u8ab2\u984c\u3001\u305d\u3057\u3066\u672a\u6765"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f32c791a6e1\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f32c791a6e1\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Biologics\" title=\"\u30d0\u30a4\u30aa\u30ed\u30b8\u30af\u30b9\">\u30d0\u30a4\u30aa\u30ed\u30b8\u30af\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#The_Case_for_Biosimilars\" title=\"\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u4e8b\u4f8b\">\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u4e8b\u4f8b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Biosimilars_Landscape_in_EU_and_USA\" title=\"\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3002EU\u3068\u7c73\u56fd\u306e\u72b6\u6cc1\">\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3002EU\u3068\u7c73\u56fd\u306e\u72b6\u6cc1<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Benefits_of_biosimilars\" title=\"\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u30e1\u30ea\u30c3\u30c8\">\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u30e1\u30ea\u30c3\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Cost_reduction_by_competition\" title=\"\u7af6\u4e89\u306b\u3088\u308b\u30b3\u30b9\u30c8\u524a\u6e1b\">\u7af6\u4e89\u306b\u3088\u308b\u30b3\u30b9\u30c8\u524a\u6e1b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Enhanced_patient_accessibility\" title=\"\u60a3\u8005\u69d8\u3078\u306e\u30a2\u30af\u30bb\u30b9\u6027\u306e\u5411\u4e0a\">\u60a3\u8005\u69d8\u3078\u306e\u30a2\u30af\u30bb\u30b9\u6027\u306e\u5411\u4e0a<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Incentive_for_innovation\" title=\"\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6\">\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Biosimilars_Challenges\" title=\"\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3002\u8ab2\u984c\">\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3002\u8ab2\u984c<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Patient_and_prescriber_education\" title=\"\u60a3\u8005\u3068\u51e6\u65b9\u8005\u306e\u6559\u80b2\">\u60a3\u8005\u3068\u51e6\u65b9\u8005\u306e\u6559\u80b2<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Extrapolation_issue\" title=\"\u5916\u633f\u306e\u554f\u984c\">\u5916\u633f\u306e\u554f\u984c<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#The_interchangeability_question\" title=\"\u4ea4\u63db\u6027\u306e\u554f\u984c\">\u4ea4\u63db\u6027\u306e\u554f\u984c<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#Rare_diseases\" title=\"\u5e0c\u5c11\u75be\u75c5\">\u5e0c\u5c11\u75be\u75c5<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/#The_Future_of_Biologics_and_Biosimilars\" title=\"\u751f\u7269\u5b66\u7684\u88fd\u5264\u3068\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u672a\u6765\">\u751f\u7269\u5b66\u7684\u88fd\u5264\u3068\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u672a\u6765<\/a><\/li><\/ul><\/nav><\/div>\n<p>A biosimilar is a biological medicine that is highly similar to an already approved biological medicine. The biosimilars market is expected to triple in size to $15 billion by 2020, McKinsey\u00a0 predicts. By that alone, we see that these medicines can transform <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30d8\u30eb\u30b9\u30b1\u30a2<\/a>. A <a href=\"http:\/\/biosimilarscouncil.org\/wp-content\/uploads\/2017\/06\/Biosimilars-Myths-v-Facts-Infographic_FINAL-6-5-17-1.pdf\">\u5831\u544a<\/a> by the Biosimilars Council (2018)\u306f\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u304c\u4eca\u5f8c10\u5e74\u9593\u3067\u6700\u5927$250\u5104\u5186\u306e\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3067\u304d\u308b\u3068\u4e88\u6e2c\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u3001\u751f\u7269\u5b66\u7684\u6cbb\u7642\u306b\u4f9d\u5b58\u3057\u3066\u3044\u308b\u4eba\u3005\u306e\u60a3\u8005\u30a2\u30af\u30bb\u30b9\u3092\u6539\u5584\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304b\uff1f\u8ab2\u984c\u3068\u6a5f\u4f1a\u306f\u4f55\u304b\uff1f\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u30e1\u30ea\u30c3\u30c8\u3082\u542b\u3081\u3066\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Biologics\"><\/span>\u30d0\u30a4\u30aa\u30ed\u30b8\u30af\u30b9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/www.fda.gov\/aboutfda\/centersoffices\/officeofmedicalproductsandtobacco\/cber\/ucm133077.htm\">\u30d0\u30a4\u30aa\u30ed\u30b8\u30af\u30b9<\/a> \u306f\u3001\u591a\u304f\u306e\u6162\u6027\u75be\u60a3\u3084\u969c\u5bb3\u3092\u6301\u3064\u75be\u60a3\u306e\u8a3a\u65ad\u3001\u6cbb\u7642\u3001\u6cbb\u7652\u306b\u7528\u3044\u3089\u308c\u308b\u3001\u751f\u4f53\u3092\u539f\u6599\u3068\u3059\u308b\u751f\u7269\u5b66\u7684\u5206\u5b50\u3067\u3042\u308b\u3002\u30db\u30eb\u30e2\u30f3\u3084\u30e2\u30ce\u30af\u30ed\u30fc\u30ca\u30eb\u6297\u4f53\u306a\u3069\u3001\u4e00\u822c\u7684\u306b\u5927\u304d\u304f\u3066\u8907\u96d1\u306a\u751f\u4f53\u5206\u5b50\u306f\u3001\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u3092\u7528\u3044\u3066\u5fae\u751f\u7269\u3084\u690d\u7269\u3001\u52d5\u7269\u306e\u7d30\u80de\u304b\u3089\u88fd\u9020\u3055\u308c\u307e\u3059\u3002\u5bbf\u4e3b\u751f\u7269\u306e\u81ea\u7136\u306a\u5909\u52d5\u306f\u3001\u751f\u7523\u3055\u308c\u308b\u6d3b\u6027\u751f\u7269\u5b66\u7684\u5206\u5b50\u306e\u69d8\u3005\u306a\u30d0\u30c3\u30c1\u9593\u306e\u5909\u52d5\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002\u901a\u5e38\u3001\u3053\u308c\u3089\u306e\u3070\u3089\u3064\u304d\u306f\u6700\u5c0f\u9650\u3067\u3001\u751f\u7269\u5b66\u7684\u6a5f\u80fd\u3092\u5909\u3048\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u4eca\u65e5\u3001\u751f\u7269\u5b66\u7684\u88fd\u5264\u306f\u3001\u591a\u304f\u306e\u75be\u60a3\u306e\u81e8\u5e8a\u7684\u4e88\u5f8c\u3092\u5de6\u53f3\u3059\u308b\u6700\u5148\u7aef\u306e\u6280\u8853\u306e\u4e00\u3064\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5206\u5b50\u306e\u6cbb\u7642\u306e\u53ef\u80fd\u6027\u306f\u3001\u7cd6\u5c3f\u75c5\u3001\u81ea\u5df1\u514d\u75ab\u75be\u60a3\u3001\u764c\u306a\u3069\u591a\u5c90\u306b\u308f\u305f\u3063\u3066\u3044\u308b\u3002\u3057\u304b\u3057\u3001\u751f\u7269\u5b66\u7684\u88fd\u5264\u306f\u3001\u305d\u306e\u9700\u8981\u306e\u9ad8\u3055\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u60a3\u8005\u306b\u3068\u3063\u3066\u5927\u304d\u306a\u969c\u58c1\u3068\u306a\u308b\u9ad8\u984d\u306a\u8cbb\u7528\u304c\u304b\u304b\u308b\u3053\u3068\u304c\u5927\u304d\u306a\u6b20\u70b9\u3067\u3059\u3002\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u5229\u70b9\u3092\u77e5\u308b\u3053\u3068\u306f\u975e\u5e38\u306b\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_Case_for_Biosimilars\"><\/span>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u4e8b\u4f8b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6d88\u8cbb\u8005\u306e\u30b3\u30b9\u30c8\u8ca0\u62c5\u306f\u3001\u7b2c\u4e8c\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u3042\u308b\u751f\u7269\u5b66\u7684\u88fd\u5264\u306b\u3088\u3063\u3066\u8efd\u6e1b\u3055\u308c\u308b\u3068\u601d\u308f\u308c\u308b\u3002 <a href=\"https:\/\/en.wikipedia.org\/wiki\/Biosimilar\"><strong>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc<\/strong><\/a>.\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Molecular-Biology?utm_source=Blog&amp;utm_medium=pPost&amp;utm_campaign=Biosimilars\">\u751f\u7269\u5b66\u7684\u5206\u5b50<\/a> \u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 <em>\"\u65e2\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u53c2\u8003\u751f\u7269\u5b66\u7684\u88fd\u5264\u3068\u306e\u9ad8\u3044\u985e\u4f3c\u6027\"<\/em>.\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3068\u3057\u3066\u8a8d\u5b9a\u3055\u308c\u308b\u305f\u3081\u306b\u306f\u3001\u3042\u308b\u5206\u5b50\u304c\u4ee5\u4e0b\u306e\u70b9\u3067\u540c\u7b49\u306e\u7279\u6027\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <em>\"structure, biological activity and efficacy, safety and immunogenicity profile\"<\/em>\u306e\u3088\u3046\u306b\u3001\u30aa\u30ea\u30b8\u30ca\u30eb\u306e\u53c2\u7167\u5206\u5b50\u306b\u8fd1\u3044\u3082\u306e\u3067\u3059\u3002\u751f\u7269\u5b66\u7684\u88fd\u5264\u3068\u540c\u69d8\u306b\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3082\u751f\u7269\u5b66\u7684\u306b\u88fd\u9020\u3055\u308c\u308b\u3002\u305d\u306e\u305f\u3081\u3001\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u5f53\u7136\u306e\u3053\u3068\u306a\u304c\u3089\u5909\u52d5\u304c\u3042\u308a\u3001\u305d\u306e\u7d50\u679c\u3001\u57fa\u6e96\u3068\u306a\u308b\u533b\u85ac\u54c1\u3068\u306e\u9593\u306b\u56fa\u6709\u306e\u5909\u52d5\u304c\u751f\u3058\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u7279\u6027\u3092\u660e\u3089\u304b\u306b\u3057\u3001\u627f\u8a8d\u3092\u5f97\u308b\u3053\u3068\u306f\u56f0\u96e3\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u3053\u308c\u3089\u306e\u3070\u3089\u3064\u304d\u304c\u81e8\u5e8a\u4e0a\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u306a\u3044\u3053\u3068\u304c\u8a3c\u660e\u3055\u308c\u308c\u3070\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u3002<\/p>\n<p>\u53c2\u7167\u7528\u751f\u7269\u88fd\u5264\u306e\u5206\u5b50\u306f\u3001\u4ee5\u4e0b\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u3092\u542b\u3080\u300c\u72ec\u7acb\u578b\u300d\u306e\u7533\u8acb\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Clinical-Trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u81e8\u5e8a\u8a66\u9a13<\/a> \u305d\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u5b9f\u8a3c\u3055\u308c\u305f\u3082\u306e\u304c\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3067\u3059\u3002\u30aa\u30ea\u30b8\u30ca\u30eb\u306e\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u7279\u8a31\u304c\u5207\u308c\u308b\u3068\u3001\u4ed6\u306e\u7af6\u5408\u4f01\u696d\u306f\u3001\u5bfe\u5fdc\u3059\u308b\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u88fd\u54c1\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u7533\u8acb\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u6700\u7d42\u7684\u306a\u76ee\u6a19\u306f\u3001\u5358\u72ec\u3067\u306e\u5b89\u5168\u6027\u3084\u6709\u52b9\u6027\u306e\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u78ba\u7acb\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u57fa\u6e96\u3068\u306a\u308b\u533b\u85ac\u54c1\u3068\u306e\u300c\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u6027\u300d\u3092\u8a3c\u660e\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f\u3001\u5f93\u6765\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u7d4c\u308b\u4ee3\u308f\u308a\u306b\u3001\u6bd4\u8f03\u81e8\u5e8a\u8a66\u9a13\u3092\u7d4c\u3066\u3001\u57fa\u6e96\u5206\u5b50\u3068\u306e\u81e8\u5e8a\u7684\u5dee\u7570\u304c\u306a\u3044\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3002\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u5206\u5b50\u306f\u3001\u57fa\u6e96\u5206\u5b50\u306e\u9577\u5e74\u306e\u4f7f\u7528\u304b\u3089\u5f97\u3089\u308c\u305f\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u77e5\u8b58\u3092\u5229\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u898f\u5236\u9762\u3067\u306f\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u3001\u30aa\u30ea\u30b8\u30ca\u30eb\u306e\u53c2\u7167\u751f\u7269\u5b66\u7684\u88fd\u5264\u5206\u5b50\u3068\u540c\u3058\u81e8\u5e8a\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u7e70\u308a\u8fd4\u3059\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30e1\u30fc\u30ab\u30fc\u3068\u6d88\u8cbb\u8005\u306e\u53cc\u65b9\u304c\u8ca0\u62c5\u3059\u308b\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u591a\u304f\u306e\u30dc\u30e9\u30f3\u30c6\u30a3\u30a2\u3084\u60a3\u8005\u3055\u3093\u304c\u4e0d\u5fc5\u8981\u306a\u8a66\u9a13\u306b\u53c2\u52a0\u3057\u306a\u304f\u3066\u6e08\u3080\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002\u5168\u4f53\u3068\u3057\u3066\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u627f\u8a8d\u7d4c\u8def\u306f\u3001\u30d6\u30e9\u30f3\u30c9\u5316\u3055\u308c\u305f\u30aa\u30ea\u30b8\u30ca\u30eb\u306e\u751f\u7269\u88fd\u5264\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u5408\u7406\u7684\u3067\u30b7\u30f3\u30d7\u30eb\u304b\u3064\u4f4e\u30b3\u30b9\u30c8\u3067\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f\u3001\u6709\u52b9\u6027\u3084\u5b89\u5168\u6027\u306b\u59a5\u5354\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u60a3\u8005\u304c\u3088\u308a\u65e9\u304f\u3001\u3088\u308a\u5b89\u304f\u533b\u7642\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002\u5305\u62ec\u7684\u306a <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0305737216300172\">\u30ea\u30b9\u30c8<\/a> FDA\u304a\u3088\u3073EMA\u3067\u627f\u8a8d\u3055\u308c\u305f\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u6570\u306f\u3001\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002 <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6172013\/table\/t1-dic-7-212543\/?report=objectonly\">\u3053\u308c<\/a>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Biosimilars_Landscape_in_EU_and_USA\"><\/span>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3002EU\u3068\u7c73\u56fd\u306e\u72b6\u6cc1<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306f\u3001\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u306b\u304a\u3051\u308b\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u627f\u8a8d\u306e\u305f\u3081\u306e\u5c02\u7528\u30eb\u30fc\u30c8\u3092\u958b\u62d3\u3057\u3001\u6700\u521d\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\uff08\u203b\uff09\u3092\u627f\u8a8d\u3057\u307e\u3057\u305f\u3002<a href=\"https:\/\/www.omnitrope.com\/about\/about-omnitrope\/\">\u30aa\u30e0\u30cb\u30c8\u30ed\u30fc\u30d7<\/a>)\u30922006\u5e74\u306b\u767a\u58f2\u3057\u307e\u3057\u305f\u3002\u73fe\u5728\u3001EU\u306f\u4e16\u754c\u3067\u6700\u3082\u6210\u719f\u3057\u305f\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u5e02\u5834\u3067\u3059\u3002\u5b9f\u969b\u3001EU\u304c\u5c0e\u5165\u3057\u305f\u898f\u5236\u306f\u3001\u4e16\u754c\u306e\u4ed6\u306e\u5730\u57df\u306b\u304a\u3051\u308b\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u958b\u767a\u306e\u57fa\u8abf\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 <strong>2018\u5e743\u6708\u73fe\u5728\u3001EU\u59d4\u54e1\u4f1a\u304c\u627f\u8a8d\u3057\u3066\u3044\u308b\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f40\u7a2e\u985e\u4ee5\u4e0a\u3042\u308a\u307e\u3059\u3002<\/strong> \u3053\u306e\u6570\u5b57\u306f\u3001EMA\u3067\u5be9\u67fb\u4e2d\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\u304c\u7d99\u7d9a\u7684\u306b\u62e1\u5927\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u3055\u3089\u306b\u5897\u52a0\u3059\u308b\u3053\u3068\u304c\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002\u904e\u53bb10\u5e74\u9593\u3067\u3001EU\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u5e02\u5834\u3067\u306e\u7af6\u4e89\u306b\u304a\u3044\u3066\u76ee\u306b\u898b\u3048\u308b\u512a\u4f4d\u6027\u3092\u78ba\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002EU\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u5e02\u5834\u306f\u30012018\u5e74\u672b\u307e\u3067\u306b10\u51042,400\u4e07\u30c9\u30eb\u8fd1\u304f\u306b\u306a\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u4e00\u65b9\u3001\u7c73\u56fd\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u5e02\u5834\u306f\u307e\u3060\u304b\u306a\u308a\u30d5\u30e9\u30c3\u30c8\u3067\u3001\u898f\u5236\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u6574\u3044\u3064\u3064\u3042\u308b\u4e2d\u3067\u5f90\u3005\u306b\u53f0\u982d\u3057\u3066\u304d\u3066\u3044\u307e\u3059\u3002FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u304c\u6700\u521d\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3092\u627f\u8a8d\u3057\u305f\u306e\u306f\u30012015\u5e74\u306b\u306a\u3063\u3066\u304b\u3089\u3067\u3059(<a href=\"http:\/\/chemocare.com\/chemotherapy\/drug-info\/filgrastim.aspx\">\u30d5\u30a3\u30eb\u30b0\u30e9\u30b9\u30c1\u30e0<\/a>). <strong>2018\u5e747\u6708\u6642\u70b9\u3067\u306f\u3001\u305f\u3063\u305f <a href=\"https:\/\/www.fda.gov\/drugs\/developmentapprovalprocess\/howdrugsaredevelopedandapproved\/approvalapplications\/therapeuticbiologicapplications\/biosimilars\/ucm580432.htm\">12\u306eFDA\u627f\u8a8d\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc<\/a> \u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/strong> \u9593\u9055\u3044\u306a\u304f\u3001\u30a2\u30e1\u30ea\u30ab\u306f\u91cd\u8981\u306a\u56fd\u3067\u3059\u3002 <a href=\"https:\/\/www.rdmag.com\/article\/2016\/04\/us-biosimilar-market-2016\">\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u5e02\u5834<\/a>.\u3057\u304b\u3057\u3001\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc\u306e\u9593\u3067\u9032\u884c\u4e2d\u306e\u7279\u8a31\u7d1b\u4e89\u3092\u542b\u3080\u591a\u304f\u306e\u4e88\u6e2c\u4e0d\u53ef\u80fd\u306a\u8981\u56e0\u306b\u3088\u308a\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u671f\u9593\u304c\u5ef6\u9577\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002RAND Corporation\u306b\u3088\u308b\u3068\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f\u3001\u7c73\u56fd\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3051\u308b\u751f\u7269\u88fd\u5264\u306e\u30b3\u30b9\u30c8\u3092\u7d041,000\u5104\u5186\u524a\u6e1b\u3067\u304d\u308b\u3068\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.rand.org\/content\/dam\/rand\/pubs\/perspectives\/PE200\/PE264\/RAND_PE264.pdf\">$54\u5104\u5186<\/a> \u3092\u4eca\u5f8c10\u5e74\u9593\u306b\u6e21\u3063\u3066\u63d0\u4f9b\u3057\u3066\u3044\u304d\u307e\u3059\u3002\u305d\u308c\u3067\u306f\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u30e1\u30ea\u30c3\u30c8\u3092\u898b\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Benefits_of_biosimilars\"><\/span>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u30e1\u30ea\u30c3\u30c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Cost_reduction_by_competition\"><\/span>\u7af6\u4e89\u306b\u3088\u308b\u30b3\u30b9\u30c8\u524a\u6e1b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>\u751f\u7269\u5b66\u7684\u88fd\u5264\u306f\u672c\u5f53\u306b\u9ad8\u4fa1\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u751f\u7269\u5b66\u7684\u88fd\u5264\u3067\u3042\u308b\u304c\u3093\u6cbb\u7642\u85ac\u306f\u3001\u60a3\u8005\u4e00\u4eba\u3042\u305f\u308a\u5e74\u9593\u6570\u767e\u30c9\u30eb\u3001\u6570\u5343\u30c9\u30eb\u304b\u304b\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u8907\u6570\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u304c\u5e02\u5834\u306b\u51fa\u56de\u308b\u3053\u3068\u3067\u3001\u57fa\u6e96\u85ac\u306e\u72ec\u5360\u72b6\u614b\u304c\u89e3\u6d88\u3055\u308c\u3001\u30b3\u30b9\u30c8\u306e\u4f4e\u6e1b\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Enhanced_patient_accessibility\"><\/span>\u60a3\u8005\u69d8\u3078\u306e\u30a2\u30af\u30bb\u30b9\u6027\u306e\u5411\u4e0a<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>\u3088\u308a\u591a\u304f\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u304c\u6d41\u901a\u3059\u308b\u3053\u3068\u3067\u3001\u4e16\u754c\u4e2d\u306e\u3088\u308a\u591a\u304f\u306e\u60a3\u8005\u3055\u3093\u304c\u3053\u308c\u3089\u306e\u6cbb\u7642\u6cd5\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Incentive_for_innovation\"><\/span>\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f\u3001\u6a19\u6e96\u85ac\u306e\u7279\u8a31\u304c\u5207\u308c\u308b\u307e\u3067\u306f\u8ca9\u58f2\u3067\u304d\u307e\u305b\u3093\u3002\u7279\u8a31\u304c\u5207\u308c\u305f\u5f8c\u3082\u5927\u304d\u306a\u5e02\u5834\u30b7\u30a7\u30a2\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u7279\u8a31\u6027\u306e\u3042\u308b\u9769\u65b0\u7684\u306a\u751f\u7269\u5b66\u7684\u65b0\u88fd\u54c1\u304c\u5fc5\u8981\u306b\u306a\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u88fd\u85ac\u4f1a\u793e\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306b\u3001\u6700\u5148\u7aef\u306e\u7814\u7a76\u958b\u767a\u5206\u91ce\u306b\u3082\u3063\u3068\u6295\u8cc7\u3059\u308b\u3053\u3068\u304c\u671b\u307e\u308c\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Biosimilars_Challenges\"><\/span>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3002\u8ab2\u984c<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f\u5b89\u4fa1\u3067\u3042\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u307e\u3067\u306b\u306f\u591a\u304f\u306e\u8ab2\u984c\u304c\u3042\u308a\u307e\u3059\u3002\u73fe\u5728\u9032\u884c\u4e2d\u306e\u8ab2\u984c\u306b\u306f\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Patient_and_prescriber_education\"><\/span>\u60a3\u8005\u3068\u51e6\u65b9\u8005\u306e\u6559\u80b2<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306f\u3001EU\u3067\u306f10\u5e74\u4ee5\u4e0a\u524d\u304b\u3089\u5b58\u5728\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u3053\u306e\u5206\u91ce\u4ee5\u5916\u306e\u4eba\u306b\u3068\u3063\u3066\u306f\u307e\u3060\u76ee\u65b0\u3057\u3044\u3082\u306e\u3067\u3059\u3002\u3042\u308b\u6587\u732e\u306b\u3088\u308b\u3068 <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4889091\/\">2014\u5e74\u306e\u8abf\u67fb<\/a>\u307e\u305f\u3001\u8a3a\u65ad\u3092\u53d7\u3051\u3066\u3044\u308b\u4eba\u306e\u7d0430%\u304c\u3001\u85ac\u306e\u9078\u629e\u306f\u533b\u85ac\u54c1\u30e1\u30fc\u30ab\u30fc\u306e\u30a2\u30a4\u30c7\u30f3\u30c6\u30a3\u30c6\u30a3\u306b\u5927\u304d\u304f\u5f71\u97ff\u3055\u308c\u308b\u3068\u7b54\u3048\u3066\u3044\u307e\u3059\u3002\u88fd\u85ac\u4f1a\u793e\u3060\u3051\u3067\u306a\u304f\u3001\u533b\u7642\u6a5f\u95a2\u3067\u3082\u5e83\u304f\u6559\u80b2\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u51e6\u65b9\u8005\u306f\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3092\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u78ba\u8a8d\u3001\u85ac\u5264\u5e2b\u3068\u306e\u4ee3\u66ff\u54c1\u306e\u76f8\u8ac7\u306a\u3069\u3001\u4f59\u8a08\u306a\u4ed5\u4e8b\u3068\u8003\u3048\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3055\u3089\u306b\u3001\u4fdd\u967a\u4f1a\u793e\u304c\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3078\u306e\u5207\u308a\u66ff\u3048\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u3053\u3068\u306b\u540c\u610f\u3057\u3066\u3044\u308b\u3053\u3068\u3082\u3001\u72b6\u6cc1\u3092\u8907\u96d1\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Physics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u533b\u5e2b<\/a>,<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/pharmacology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\"> \u85ac\u5264\u5e2b<\/a> \u305d\u3057\u3066\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306b\u5207\u308a\u66ff\u3048\u308b\u3053\u3068\u306e\u30e1\u30ea\u30c3\u30c8\u3092\u7406\u89e3\u3057\u3066\u3082\u3089\u3044\u3001\u7d0d\u5f97\u3057\u3066\u3082\u3089\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Extrapolation_issue\"><\/span>\u5916\u633f\u306e\u554f\u984c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4894513\/\">\u5916\u633f\u3059\u308b<\/a> \u3068\u306f\u3001\u300c\u3042\u308b\u85ac\u306b\u5bfe\u3057\u3066\u3001\u305d\u306e\u9069\u5fdc\u3092\u88cf\u4ed8\u3051\u308b\u72ec\u81ea\u306e\u3001\u3042\u308b\u3044\u306f\u65b0\u305f\u306a\u81e8\u5e8a\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u8a66\u9a13\u3092\u884c\u308f\u305a\u306b\u3001\u305d\u306e\u85ac\u306e\u81e8\u5e8a\u9069\u5fdc\u3092\u8a8d\u3081\u308b\u30d7\u30ed\u30bb\u30b9\u300d\u306e\u3053\u3068\u3067\u3059\u3002\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u304c\u3001\u57fa\u6e96\u85ac\u306b\u306fOK\u304c\u51fa\u3066\u3044\u308b\u9069\u5fdc\u5916\u306e\u9069\u5fdc\u75c7\u306b\u51e6\u65b9\u3055\u308c\u308b\u304b\u3069\u3046\u304b\u306f\u3001\u30b0\u30ec\u30fc\u30be\u30fc\u30f3\u3067\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u9069\u5fdc\u75c7\u306b\u5bfe\u3057\u3066\u306f\u3001\u9069\u5207\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u8a2d\u5b9a\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u305d\u3046\u3057\u306a\u3044\u3068\u3001\u75c5\u9662\u3084\u85ac\u5c40\u306f\u3001\u57fa\u6e96\u3068\u306a\u308b\u5206\u5b50\u3068\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u4e21\u65b9\u3092\u53d6\u308a\u6271\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u304f\u306a\u308a\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3092\u51e6\u65b9\u3059\u308b\u3053\u3068\u306b\u3088\u308b\u30b3\u30b9\u30c8\u9762\u3067\u306e\u30e1\u30ea\u30c3\u30c8\u304c\u306a\u304f\u306a\u3063\u3066\u3057\u307e\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"The_interchangeability_question\"><\/span>\u4ea4\u63db\u6027\u306e\u554f\u984c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>\u4e92\u63db\u6027\u3068\u306f\u30012\u3064\u306e\u88fd\u54c1\u3092\u884c\u304d\u6765\u3057\u3066\u3082\u3001\u305d\u308c\u305e\u308c\u306e\u88fd\u54c1\u3092\u5358\u72ec\u3067\u4f7f\u7528\u3057\u305f\u5834\u5408\u3068\u6bd4\u8f03\u3057\u3066\u3001\u6709\u52b9\u6027\u3084\u5b89\u5168\u6027\u306b\u5f71\u97ff\u304c\u306a\u3044\u3053\u3068\u3092\u793a\u3057\u307e\u3059\u3002\u3053\u308c\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3044\u304f\u3064\u304b\u3042\u308a\u307e\u3059\u304c\u3001\u5730\u57df\u306e\u51e6\u65b9\u8005\u3084\u85ac\u5c40\u306e\u30ec\u30d9\u30eb\u3067\u306f\u4e0d\u78ba\u5b9f\u6027\u304c\u9ad8\u3044\u306e\u304c\u73fe\u72b6\u3067\u3059\u3002\u85ac\u5264\u5e2b\u304c\u3001\u660e\u78ba\u306a\u51e6\u65b9\u7b8b\u306a\u3057\u306b\u3001\u57fa\u6e96\u5206\u5b50\u3092\u4e92\u63db\u6027\u306e\u3042\u308b\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306b\u3001\u307e\u305f\u306f\u305d\u306e\u9006\u306b\u300c\u7f6e\u63db\u300d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u306f\u3001\u548c\u89e3\u3092\u6c42\u3081\u308b\u3082\u3046\u4e00\u3064\u306e\u624b\u6bb5\u3067\u3059\u3002<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Rare_diseases\"><\/span>\u5e0c\u5c11\u75be\u75c5<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>\u5e0c\u5c11\u75be\u75c5\u306e\u6cbb\u7642\u306b\u306f\u3001\u9ad8\u984d\u306a\u8cbb\u7528\u304c\u5fc5\u8981\u306a\u300c\u30aa\u30fc\u30d5\u30a1\u30f3\u30c9\u30e9\u30c3\u30b0\u300d\u304c\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u304c\u591a\u3044\u3002\u3053\u306e\u3088\u3046\u306a\u30aa\u30fc\u30d5\u30a1\u30f3\u30c9\u30e9\u30c3\u30b0\u306b\u5bfe\u5fdc\u3059\u308b\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u304c\u958b\u767a\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u73fe\u5b9f\u7684\u306b\u306f\u591a\u304f\u306e\u30cf\u30fc\u30c9\u30eb\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305a\u3001\u7b2cI\u76f8\u304a\u3088\u3073\u7b2cIII\u76f8\u8a66\u9a13\u306e\u305f\u3081\u306b\u3001\u5341\u5206\u306a\u6570\u306e\u975e\u5747\u8cea\u306a\u96c6\u56e3\u3092\u5f97\u308b\u3053\u3068\u304c\u56f0\u96e3\u3067\u3059\u3002\u3055\u3089\u306b\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u5341\u5206\u306a\u30d0\u30c3\u30c1\u3092\u88fd\u9020\u3057\u3066\u30d0\u30c3\u30c1\u9593\u306e\u5909\u52d5\u6027\u3092\u8abf\u67fb\u3057\u3001\u5e83\u7bc4\u306a\u6bd4\u8f03\u53ef\u80fd\u6027\u30c7\u30fc\u30bf\u3092\u69cb\u7bc9\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u30b3\u30b9\u30c8\u304c\u4e0d\u91e3\u308a\u5408\u3044\u306b\u9ad8\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_Future_of_Biologics_and_Biosimilars\"><\/span>\u751f\u7269\u5b66\u7684\u88fd\u5264\u3068\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u672a\u6765<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u7523\u696d\u3068\u305d\u306e\u898f\u5236\u306f\u3001\u904e\u53bb10\u5e74\u9593\u3067\u98db\u8e8d\u7684\u306b\u6210\u9577\u3057\u3066\u3044\u307e\u3059\u3002\u6700\u3082\u591a\u304f\u51e6\u65b9\u3055\u308c\u3066\u3044\u308b\u751f\u7269\u88fd\u5264\u306e\u4e00\u90e8\u304c\u8fd1\u3044\u5c06\u6765\u306b\u7279\u8a31\u5207\u308c\u3092\u8fce\u3048\u308b\u3053\u3068\u304b\u3089\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u5e02\u5834\u306f\u3055\u3089\u306a\u308b\u6210\u9577\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306b\u3088\u308b\u5e02\u5834\u7af6\u4e89\u306f\u3001\u30d6\u30e9\u30f3\u30c9\u533b\u85ac\u54c1\u696d\u754c\u306e\u72ec\u5360\u72b6\u614b\u3092\u8105\u304b\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u3070\u3057\u3070\u3001\u5927\u624b\u88fd\u85ac\u4f1a\u793e\u306f\u77e5\u7684\u8ca1\u7523\u6a29\u306e\u89b3\u70b9\u304b\u3089\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u4f01\u696d\u3092\u59a8\u5bb3\u3057\u3066\u3044\u308b\u3068\u898b\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u4eca\u5f8c\u6570\u5e74\u9593\u3067\u3001\u898f\u5236\u5f53\u5c40\u306f\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u8ca9\u58f2\u3068\u51e6\u65b9\u306b\u304a\u3051\u308b\u3044\u304f\u3064\u304b\u306e\u30b0\u30ec\u30fc\u30be\u30fc\u30f3\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3001\u3088\u308a\u5177\u4f53\u7684\u306a\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u52a0\u3048\u3066\u3001\u533b\u7642\u5f93\u4e8b\u8005\u3084\u6d88\u8cbb\u8005\u3078\u306e\u6559\u80b2\u3001\u65b0\u305f\u306a\u958b\u767a\u3084\u5546\u696d\u30e2\u30c7\u30eb\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u3067\u3001\u65b0\u305f\u306a\u30d6\u30ed\u30c3\u30af\u30d0\u30b9\u30bf\u30fc\u3068\u306a\u308b\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3092\u751f\u307f\u51fa\u3059\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u5229\u70b9\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n<p>&#8212;-<br \/>\n<b>\u304b\u3089\u306e\u76f8\u8ac7\u306b\u4e57\u3063\u3066\u307b\u3057\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u30d0\u30a4\u30aa\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30b7\u30e3\u30f3<\/a>?\u3092\u96c7\u3046\u3002\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30fb\u30d0\u30a4\u30aa\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9<\/a>\u00a0\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/b><b>\u00a0\u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u3001\u898b\u7a4d\u3082\u308a\u3092\u3082\u3089\u3046\u306e\u306f\u7121\u6599\u3067\u3059\u3002<\/b><\/p>\n<p>\u95a2\u9023\u3059\u308b\u5c02\u9580\u5bb6<br \/>\n<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u30d0\u30a4\u30aa\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30b7\u30e3\u30f3\u306e\u63a1\u7528<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Molecular-Biology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u5206\u5b50\u751f\u7269\u5b66\u8005\u306e\u63a1\u7528\u00a0<\/a>\u00a0\u00a0 \u00a0\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u30d0\u30a4\u30aa\u30b9\u30bf\u30c6\u30a3\u30b7\u30e3\u30f3\u306e\u63a1\u7528<\/a><\/p>\n<p>\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u79d1\u5b66\u8005\u306b\u76f8\u8ac7\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b\uff1f10,000\u4eba\u4ee5\u4e0a\u306e\u5c02\u9580\u5bb6\u306e\u4e2d\u304b\u3089 <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">\u30b3\u30e9\u30d6\u30c4\u30ea\u30fc<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>A biosimilar is a biological medicine that is highly similar to an already approved biological medicine. The biosimilars market is expected to triple in size to $15 billion by 2020, McKinsey\u00a0 predicts. By that alone, we see that these medicines can transform healthcare. A report by the Biosimilars Council (2018) predicts that biosimilars could save costs of up to $250 billion over the next decade. Can these products improve patient access for those depending on biologic treatments? What are the challenges and opportunities? This includes benefits of biosimilars: Biologics Biologics are biological molecules, sourced from living organisms, used to diagnose, treat and cure many chronic and disabling diseases. The typically<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":43,"featured_media":4695,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,443,435],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Biosimilars: Benefits, Challenges and Future - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"The biosimilars market is expected to triple in size to $15 billion by 2020. Let&#039;s look at benefits of biosimilars.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biosimilars: Benefits, Challenges and Future\" \/>\n<meta property=\"og:description\" content=\"The biosimilars market is expected to triple in size to $15 billion by 2020. Let&#039;s look at benefits of biosimilars.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/biosimilars-benefits-challenges-and-future\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2018-10-29T15:55:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-11-08T16:48:44+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2018\/10\/syringe-1884784_1280.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"768\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Maya Raghunandan\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Maya Raghunandan\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"7\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Biosimilars: Benefits, Challenges and Future - The Kolabtree Blog","description":"The biosimilars market is expected to triple in size to $15 billion by 2020. 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Currently, she is a cancer biology scientist at Universit\u00e9 Catholique de Louvain, Brussels, Belgium. In her spare time, she writes about cool science discoveries in her jargon-free blog http:\/\/www.sciencesnippets.org\/. Because, science doesn\u2019t have to sound complicated. Instead, it must be comprehensible for everyone.","url":"https:\/\/www.kolabtree.com\/blog\/ja\/author\/mayanandan\/"}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/4681"}],"collection":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/users\/43"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/comments?post=4681"}],"version-history":[{"count":9,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/4681\/revisions"}],"predecessor-version":[{"id":8507,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/4681\/revisions\/8507"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media\/4695"}],"wp:attachment":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media?parent=4681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/categories?post=4681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/tags?post=4681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}