{"id":1192,"date":"2020-02-03T00:00:24","date_gmt":"2020-02-02T16:00:24","guid":{"rendered":"https:\/\/clarivate.com\/tw\/2020\/02\/03\/%e7%94%9f%e7%89%a9%e7%9b%b8%e4%bc%bc%e6%80%a7%e8%97%a5%e5%93%81%e9%a6%96%e5%80%8b%e5%8d%81%e5%b9%b4%e9%87%8c%e7%a8%8b%e7%a2%91%e8%87%a8%e8%bf%91%ef%bc%81%e7%b4%af%e8%a8%88%e5%b7%b2%e6%a0%b8%e5%87%8626\/?lang=zh-hant"},"modified":"2024-10-24T00:27:42","modified_gmt":"2024-10-24T00:27:42","slug":"cder-approval-numbers-show-biosimilar-advance-steady-pace-of-novel-blas","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/zh\/blog\/cder-approval-numbers-show-biosimilar-advance-steady-pace-of-novel-blas\/","title":{"rendered":"\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7d2f\u8a08\u5df2\u6838\u51c626\u7522\u54c1\uff0c\u7368\u4f54\u671f\u6210\u95dc\u9375\u7af6\u722d\u8981\u7d20"},"content":{"rendered":"<p><em><strong>FDA\u85e5\u7269\u8a55\u4f30\u8207\u7814\u7a76\u4e2d\u5fc3\uff08CDER\uff09\u6279\u51c6\u6578\u91cf\u986f\u793a\uff0c\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u52a0\u901f\u767c\u5c55\uff0c\u5275\u65b0\u751f\u7269\u85e5\u7a69\u6b65\u589e\u9577<\/strong><\/em><\/p>\n<p>&nbsp;<\/p>\n<p><em>\u672c\u6587\u8b6f\u81ea\u00a0<a href=\"https:\/\/www.bioworld.com\/articles\/432239-cder-approval-numbers-show-biosimilar-advance-steady-pace-of-novel-blas\" target=\"_blank\" rel=\"noopener noreferrer\">\u79d1\u777f\u552f\u5b89 BioWorld \u5831\u5c0e<\/a>\uff0c\u539f\u6587\u4f5c\u8005\u70ba\u00a0Mari Serebrov<\/em><\/p>\n<p>&nbsp;<\/p>\n<p>2010\u5e74\u7f8e\u570b\u570b\u6703\u9996\u6b21\u70ba\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u6253\u958b\u5927\u9580\u4ee5\u4f86\uff0c2019\u5e74FDA\u5c31\u6279\u51c6\u4e86\u8207\u5275\u65b0\u751f\u7269\u85e5\u6578\u91cf\u76f8\u7576\u7684\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\u3002<\/p>\n<p>\u96a8\u8457\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u9996\u500b\u5341\u5e74\u91cc\u7a0b\u7891\u7684\u81e8\u8fd1\uff0c2019\u5e74FDA\u85e5\u7269\u8a55\u4f30\u8207\u7814\u7a76\u4e2d\u5fc3\uff08CDER\uff09\u5171\u6279\u51c6\u4e8610\u6b3e\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\uff0c\u6d89\u53ca7\u7a2e\u91cd\u78c5\u7d1a\u751f\u7269\u85e5\uff0c\u622a\u81f32019\u5e74\u5e95\uff0c\u6838\u51c6\u7684\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7d2f\u8a08\u5df2\u905426\u7a2e\u3002\u8207\u6b64\u540c\u6642\uff0c2019\u5e74CDER\u9084\u6279\u51c6\u4e8612\u7a2e\u5275\u65b0\u751f\u7269\u85e5\uff0c\u96d6\u7136\u4f4e\u65bc\u8fd1\u5169\u5e74\u6bcf\u5e74\u6279\u51c6\u7684\u6578\u91cf\uff0c\u4f46\u8207\u9019\u5341\u5e74\u7684\u6700\u521d\u5e7e\u5e74\u76f8\u6bd4\uff0cCDER\u6279\u51c6\u7684\u65b0\u751f\u7269\u88fd\u5291\u8a31\u53ef\u7533\u8acb\uff08BLA\uff09\u6578\u91cf\u5df2\u662f\u6700\u521d\u5e7e\u5e74\u7684\u5169\u500d\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>CDER\u6279\u51c6\u7684\u65b0\u751f\u7269\u88fd\u5291\u8a31\u53ef\u7533\u8acb\uff08BLA\uff09<\/strong><\/h3>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-5806 size-full\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig1_FDA_10-years-approval.jpg\" alt=\"\" width=\"838\" height=\"615\" srcset=\"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig1_FDA_10-years-approval.jpg 838w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig1_FDA_10-years-approval-300x220.jpg 300w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig1_FDA_10-years-approval-768x564.jpg 768w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig1_FDA_10-years-approval-55x40.jpg 55w\" sizes=\"auto, (max-width: 838px) 100vw, 838px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>\u96a8\u8457\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\u7684\u6838\u51c6\uff0c\u5c07\u5728\u9019\u4e9b\u9678\u7e8c\u4e0a\u5e02\u7684\u7522\u54c1\u4e2d\u9010\u6b65\u5f62\u6210\u5e02\u5834\u7af6\u722d\uff0c\u524d\u9762\u63d0\u53ca\u76847\u7a2e\u91cd\u78c5\u7d1a\u539f\u5ee0\u751f\u7269\u85e5\uff0c\u8fc4\u4eca\u81f3\u5c11\u5df2\u6709\u4e00\u7a2e\u4eff\u88fd\u7522\u54c1\u6838\u51c6\u3002\u4f8b\u5982\uff0c2019\u5e74\u6279\u51c6\u768410\u7a2e\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\u4e2d\u67093\u7a2e\u662f\u7f85\u6c0f\uff08Roche Holding AG\uff09\u4e73\u817a\u764c\u85e5\u7269\u8cc0\u764c\u5e73\uff08Herceptin\uff0ctrastuzumab\uff09\u7684\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\uff0c\u800c\u8a72\u85e5\u6b64\u524d\u5df2\u6709\u5169\u6b3e\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\u6838\u51c6\u3002<\/p>\n<p>\u6b64\u5916\uff0c2019\u5e74\u9084\u65b0\u6279\u4e86\u5169\u6b3e\u5fa9\u9081\uff08Humira\uff0cadalimumab\uff09\u7684\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\uff0c\u81f4\u4f7f\u827e\u4f2f\u7dad\uff08Abbvie Inc.\uff09\u7684\u9019\u4e00\u8d85\u7d1a\u91cd\u78c5\u85e5\u54c1\u5df2\u6709\u4e94\u6b3e\u7af6\u722d\u7522\u54c1\u84c4\u52e2\u5f85\u767c\u3002\u96d6\u7136\u6388\u6b0a\u5408\u7d04\u53ef\u66ab\u6642\u5c07\u5fa9\u9081\u7684\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u62b5\u64cb\u5728\u7f8e\u570b\u5e02\u5834\u4e4b\u5916\u76f4\u52302023\u5e74\uff0c\u4f46\u8cc0\u764c\u5e73\u7684\u5e02\u5834\u7af6\u722d\u5df2\u65bc2019\u5e74\u62c9\u958b\u5e37\u5e55\u3002\u672a\u4f86\u5e7e\u5e74\u5728\u8a72\u9818\u57df\u767c\u751f\u7684\u8b8a\u5316\uff0c\u5c07\u70ba\u751f\u7269\u85e5\u7522\u54c1\u5728\u5176\u95dc\u9375\u5c08\u5229\u5230\u671f\u5f8c\u5982\u4f55\u53c3\u8207\u5e02\u5834\u7af6\u722d\uff0c\u63d0\u4f9b\u53c3\u8003\u8207\u898b\u89e3\u3002<\/p>\n<p>\u6839\u64da\u751f\u7269\u88fd\u5291\u50f9\u683c\u7af6\u722d\u8207\u5275\u65b0\u6cd5\u6848\uff0c\u5275\u65b0\u751f\u7269\u85e5\u64c1\u670912\u5e74\u7684\u7368\u4f54\u671f\uff0c\u53732019\u5e74\u6279\u51c6\u7684BLA\u5c07\u52302031\u5e74\u624d\u6703\u9762\u81e8\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\u7684\u7af6\u722d\uff0c\u9664\u975e\u570b\u6703\u5728\u6b64\u4e4b\u524d\u7e2e\u77ed\u5176\u7368\u4f54\u671f\u3002<\/p>\n<p>\u5f9e\u7f8e\u570b-\u58a8\u897f\u54e5-\u52a0\u62ff\u5927\u5354\u8b70\uff08USMCA\uff09\u4e2d\u79fb\u9664\u64ec\u8b70\u768410\u5e74\u7368\u4f54\u671f\u7684\u540c\u6642\uff0c\u5ddd\u666e\u653f\u5e9c\u4e5f\u70ba\u6e1b\u5c11\u7f8e\u570b\u751f\u7269\u85e5\u7368\u4f54\u671f\u63d0\u4f9b\u4e86\u4e00\u500b\u6a5f\u6703\u3002\u7f8e\u570b\u773e\u8b70\u9662\u5df2\u7d93\u901a\u904e\u4e86\u4e00\u9805\u5be6\u65bd\u8a72\u5354\u8b70\u7684\u6cd5\u6848\uff0c\u53c3\u8b70\u9662\u8ca1\u653f\u59d4\u54e1\u6703\u4e5f\u65bc\u9031\u4e00\u4ee525\u7968\u8d0a\u6210\u30013\u7968\u53cd\u5c0d\u7684\u6295\u7968\u7d50\u679c\u5c07\u8a72\u6cd5\u6848\u9001\u4ea4\u53c3\u8b70\u9662\u901a\u904e\u3002<\/p>\n<p>\u4e0d\u8ad6\u7368\u4f54\u671f\u7684\u9577\u77ed\u5982\u4f55\uff0c\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7522\u54c1\u7684\u672a\u4f86\u9084\u662f\u53d6\u6c7a\u65bc\u5f37\u52c1\u7684\u751f\u7269\u85e5\u5e02\u5834\uff0c\u8a72\u5e02\u5834\u5728\u4e16\u7d00\u4e4b\u4ea4\u5df2\u771f\u6b63\u89ba\u9192\uff0c\u4e26\u5728\u904e\u53bb\u5341\u5e74\u5df2\u670998\u7a2e\u65b0\u578b\u751f\u7269\u85e5\u6838\u51c6\u3002<\/p>\n<p>\u7531\u65bc\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7684\u958b\u767c\u6210\u672c\u548c\u5e02\u5834\u9580\u6abb\uff0c\u8a31\u591a\u751f\u7269\u85e5\u4e0d\u592a\u53ef\u80fd\u9762\u81e8\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u7684\u7af6\u722d\u3002\u6839\u64da <a href=\"https:\/\/clarivate.com\/zh-hant\/products\/biopharma\/\">Cortellis<\/a> \u8cc7\u6599\uff0c\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u7f8e\u570b\u5e02\u5834\u7684\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u958b\u767c\u6240\u7784\u6e96\u7684\u5927\u591a\u662f\u5cf0\u503c\u92b7\u552e\u984d\u8d85\u904e60\u5104\u7f8e\u5143\u7684\u5927\u7522\u54c1\u3002<\/p>\n<p>2019\u5e74\u6838\u51c6\u7684\u65b0\u578b\u751f\u7269\u85e5\u4e2d\u53ef\u80fd\u5c31\u5305\u62ec\u4e00\u4e9b\u7b26\u5408\u4e0a\u8ff0\u7279\u5fb5\u7684\u5927\u7522\u54c1\u3002\u4f8b\u5982\uff0c\u6839\u64da <a href=\"https:\/\/clarivate.com\/zh-hant\/products\/biopharma\/\">Cortellis<\/a> \u8cc7\u6599\u986f\u793a\uff0c\u827e\u4f2f\u7dad\u7684\u65b0\u578b\u514d\u75ab\u85e5\u7269Skyrizi\uff08risankizumab\uff09\uff0c\u9810\u8a08\u52302025\u5e74\u92b7\u552e\u984d\u5c07\u63a5\u8fd141.5\u5104\u7f8e\u5143\u3002\u5982\u540c2003\u5e74\u6838\u51c6\u7684\u5fa9\u9081\uff0c\u5728\u7f8e\u570b\u5e02\u5834\u7b2c\u4e03\u5e74\u4fbf\u9054\u5230\u4e8655\u5104\u7f8e\u5143\u7684\u92b7\u552e\u984d\uff0c\u751a\u81f3\u57282018\u5e74\u9054\u5230\u4e86203\u5104\u7f8e\u5143\u7684\u92b7\u552e\u984d\u5cf0\u503c\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>2019\u5e74\u6838\u51c6\u7684\u5275\u65b0\u751f\u7269\u85e5<\/strong><\/h3>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-5807 size-large\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig2_novel-biologics-fda-approved-2019-1024x631.jpg\" alt=\"\" width=\"640\" height=\"394\" srcset=\"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig2_novel-biologics-fda-approved-2019-1024x631.jpg 1024w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig2_novel-biologics-fda-approved-2019-300x185.jpg 300w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig2_novel-biologics-fda-approved-2019-768x473.jpg 768w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig2_novel-biologics-fda-approved-2019-65x40.jpg 65w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig2_novel-biologics-fda-approved-2019.jpg 1045w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>\u53e6\u4e00\u6b3e\u5275\u65b0BLA\u6279\u51c6\u7522\u54c1\u662f\u4f86\u81ea\u7f85\u6c0f\u7684Herceptin Hylecta\uff08trastuzumab\u548c\u900f\u660e\u8cea\u9178\u9176\uff09\uff0c\u5c07\u70ba\u8cc0\u764c\u5e73\u7684\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u6253\u958b\u672a\u4f86\u7684\u5927\u9580\uff0c\u901a\u904e\u65b0\u7684\u914d\u65b9\u8207\u7d44\u5408\u5ef6\u7e8c\u6b64\u85e5\u7269\u7684\u751f\u547d\u9031\u671f\u3002<\/p>\n<p>\u5118\u7ba12019\u5e74\u6279\u51c6\u7684\u65b0\u578b\u751f\u7269\u85e5\u7684\u6578\u91cf\u8f032017\u5e74\u30012018\u5e74\u6709\u6240\u6e1b\u5c11\uff0c\u4f46\u4ecd\u53602019\u5e74CDER\u6279\u51c6\u768448\u500b\u65b0\u5206\u5b50\u5be6\u9ad4\u768425\uff05\u30022018\u5e74\u662f\u65b0\u85e5\u5275\u7d00\u9304\u7684\u4e00\u5e74\uff0cCDER\u6279\u51c6\u768459\u7a2e\u65b0\u85e5\u4e2d\u670917\u7a2e\u662f\u751f\u7269\u85e5\uff0c\u5360\u6bd4\u8fd129%\u3002<\/p>\n<p>\u5c0d\u6bd42018\u5e74\u82072019\u5e74\uff0c\u6700\u5927\u7684\u5340\u5225\u5728\u65bc\u5b64\u5152\u85e5\u6279\u51c6\u6578\u91cf\u7684\u4e0b\u964d\uff0c\u7121\u8ad6\u662f\u5c0f\u5206\u5b50\u85e5\u7269\u9084\u662f\u751f\u7269\u85e5\u30022019\u5e74CDER\u6279\u51c6\u4e8621\u7a2e\u5b64\u5152\u85e5\uff0c\u800c2018\u5e74\u6279\u51c6\u4e8635\u7a2e\uff0c\u5118\u7ba1\u6578\u91cf\u6709\u6240\u4e0b\u964d\uff0c\u4f46\u6838\u51c6\u768421\u7a2e\u7f55\u898b\u75c5\u85e5\u7269\u4ecd\u53602019\u5e74\u65b0\u85e5\u6279\u51c6\u7e3d\u6578\u768444%\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u8fd110\u5e74\u6838\u51c6\u7684\u5b64\u5152\u85e5<\/strong><\/h3>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-5808 size-large\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig3_orphan-drug-approvals-2010-2019-1024x714.jpg\" alt=\"\" width=\"640\" height=\"446\" srcset=\"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig3_orphan-drug-approvals-2010-2019-1024x714.jpg 1024w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig3_orphan-drug-approvals-2010-2019-300x209.jpg 300w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig3_orphan-drug-approvals-2010-2019-768x536.jpg 768w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig3_orphan-drug-approvals-2010-2019-57x40.jpg 57w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig3_orphan-drug-approvals-2010-2019-400x280.jpg 400w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2020\/02\/fig3_orphan-drug-approvals-2010-2019.jpg 1067w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>CDER\u4e3b\u4efbJanet 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