{"id":6730,"date":"2024-05-23T18:36:52","date_gmt":"2024-05-23T10:36:52","guid":{"rendered":"https:\/\/chimebiologics.com\/?p=6730"},"modified":"2025-06-12T14:00:34","modified_gmt":"2025-06-12T06:00:34","slug":"biosimilar-regulations-in-the-us-china-and-europe","status":"publish","type":"post","link":"https:\/\/chimebiologics.com\/zh\/biosimilar-regulations-in-the-us-china-and-europe\/","title":{"rendered":"\u751f\u7269\u7c7b\u4f3c\u836f\u4e2d\u7f8e\u6b27\u6cd5\u89c4\u901f\u9012"},"content":{"rendered":"<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8\">\n.flex_column.av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8 av_two_third  avia-builder-el-0  el_before_av_one_third  avia-builder-el-first  first 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[5] [9] [10] [12] [15]<\/sup><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6736 aligncenter\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/05\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17164604864160.png\" alt=\"\" width=\"550\" height=\"267\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/05\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17164604864160.png 550w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/05\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17164604864160-300x146.png 300w\" sizes=\"auto, (max-width: 550px) 100vw, 550px\" \/><\/p>\n<p style=\"text-align: center;\">EMA-\u751f\u7269\u7c7b\u4f3c\u836f\u548c\u53c2\u7167\u836f\u83b7\u6279\u6240\u9700\u6570\u636e\u8981\u6c42\u5bf9\u6bd4<\/p>\n<p><strong><b>\u5728\u8fdb\u884c\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\u65f6\uff0c\u6709\u54ea\u4e9b\u8981\u70b9\u9700\u8981\u8003\u8651\uff1f<\/b><\/strong><\/p>\n<p>\u5e94\u57fa\u4e8e\u53c2\u7167\u836f\u7684\u7814\u7a76\u6570\u636e\uff0c\u5efa\u7acb\u5019\u9009\u836f\u7684\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5\uff08Quality Target Product Profile\uff0cQTPP\uff09\u53ca\u53ef\u63a5\u53d7\u7684\u53d8\u5316\u8303\u56f4\uff08\u4e0d\u5e94\u5bbd\u4e8e\u53c2\u7167\u836f\u7684\u53d8\u5316\u8303\u56f4\uff0c\u9664\u975e\u6709\u5145\u5206\u8bba\u8bc1\uff09\uff0c\u5e76\u4ee5\u6b64\u4e3a\u57fa\u7840\u8fdb\u884c\u5019\u9009\u836f\u7684\u5f00\u53d1\u548c\u4f18\u5316\uff0c\u5305\u62ec\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\u3002\u8fdb\u884c\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\u65f6\u5e94\u5173\u6ce8\u7684\u8981\u70b9\u5982\u4e0b<sup>[2][10][15][16]<\/sup>\uff1a<\/p>\n<p>\u8868\u8fbe\u4f53\u7cfb<\/p>\n<ul>\n<li>\u5019\u9009\u836f\u7684\u6c28\u57fa\u9178\u5e8f\u5217\u539f\u5219\u4e0a\u5e94\u4e0e\u53c2\u7167\u836f\u76f8\u540c\u3002<\/li>\n<li>\u5bf9\u4e0d\u5f71\u54cd\u4ea7\u54c1\u7279\u6027\u7684\u5fae\u5c0f\u4fee\u9970\u5dee\u5f02\uff08\u5982\u6c28\u57fa\u9178\u5e8f\u5217N\u7aef\u548cC\u672b\u7aef\u7684\u5f02\u8d28\u6027\uff09\uff0c\u5e94\u91c7\u7528\u9002\u5b9c\u7684\u65b9\u6cd5\u5bf9\u4fee\u9970\u7684\u5f02\u540c\u8fdb\u884c\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\uff0c\u5305\u62ec\u5b9a\u6027\u548c\u5b9a\u91cf\u5206\u6790\u7814\u7a76\u3002<\/li>\n<li>\u5e94\u5145\u5206\u8003\u8651\u5019\u9009\u836f\u548c\u53c2\u7167\u836f\u8868\u8fbe\u4f53\u7cfb\u4e4b\u95f4\u53ef\u80fd\u7684\u5dee\u5f02\u3002<\/li>\n<\/ul>\n<p>\u751f\u4ea7\u5de5\u827a<\/p>\n<ul>\n<li>\u5e94\u57fa\u4e8e\u5019\u9009\u836f\u53ca\u5176\u751f\u4ea7\u5de5\u827a\uff0c\u4ece\u5de5\u827a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u83b7\u53d6\u5019\u9009\u836f\u7684\u8868\u5f81\u5206\u6790\u3001\u5de5\u827a\u63a7\u5236\u548c\u8d28\u91cf\u6807\u51c6\u4fe1\u606f\u3002<\/li>\n<li>\u82e5\u5b8c\u6210\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\u540e\u8fdb\u884c\u4e86\u5019\u9009\u836f\u7684\u751f\u4ea7\u5de5\u827a\u53d8\u66f4\uff0c\u9700\u8bba\u8bc1\u53d8\u66f4\u524d\u540e\u7684\u53ef\u6bd4\u6027\uff0c\u53ef\u80fd\u9700\u8981\u989d\u5916\u7684\u7814\u7a76\u652f\u6301\u8be5\u8bba\u8bc1\u3002<\/li>\n<li>\u82e5\u5728\u5019\u9009\u836f\u5f00\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u53c2\u7167\u836f\u53d1\u751f\u4e86\u53ef\u80fd\u5f71\u54cd\u5176QTPP\u7684\u5de5\u827a\u53d8\u66f4\uff0c\u9700\u7ed3\u5408\u53d8\u66f4\u524d\u540e\u53c2\u7167\u836f\u7684\u8d28\u91cf\u5c5e\u6027\u8bc4\u4f30QTPP\u662f\u5426\u4ecd\u7136\u9002\u7528\uff0c\u4ee5\u53ca\u5bf9\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u7684\u5f71\u54cd\u3002<\/li>\n<\/ul>\n<p>\u7406\u5316\u7279\u6027<\/p>\n<ul>\n<li>\u5bf9\u53c2\u7167\u836f\u548c\u5019\u9009\u836f\u8fdb\u884c\u5168\u9762\u7684\u7406\u5316\u7279\u6027\u8bc4\u4f30\uff08\u4e00\u7ea7\u7ed3\u6784\u3001\u9ad8\u7ea7\u7ed3\u6784\u7b49\uff09\u3002<\/li>\n<li>\u53ef\u4f7f\u7528\u591a\u79cd\u5206\u6790\u65b9\u6cd5\u5bf9\u540c\u4e00\u8d28\u91cf\u5c5e\u6027\u8fdb\u884c\u8bc4\u4f30\uff0c\u6216\u91c7\u7528\u4e92\u8865\u7684\u5206\u6790\u65b9\u6cd5\u7ed3\u5408\u8fdb\u884c\u3002<\/li>\n<li>\u5206\u6790\u65b9\u6cd5\u5e94\u5177\u6709\u4e00\u5b9a\u7684\u7075\u654f\u5ea6\u548c\u4e13\u5c5e\u6027\uff0c\u80fd\u8bc6\u522b\u5019\u9009\u836f\u548c\u53c2\u7167\u836f\u7684\u76f8\u5173\u5dee\u5f02\u3002<\/li>\n<li>\u4e0d\u540c\u4e8e\u5e38\u89c4\u8d28\u91cf\u63a7\u5236\u5206\u6790\u65b9\u6cd5\uff0c\u7528\u4e8e\u4ea7\u54c1\u8868\u5f81\u7684\u5206\u6790\u65b9\u6cd5\u4e0d\u4e00\u5b9a\u9700\u8981\u9a8c\u8bc1\uff0c\u4f46\u5e94\u79d1\u5b66\u5408\u7406\u3001\u9002\u5408\u9884\u671f\u7528\u9014\uff0c\u5e76\u80fd\u63d0\u4f9b\u53ef\u91cd\u590d\u3001\u53ef\u9760\u7ed3\u679c\u3002<\/li>\n<\/ul>\n<p>\u751f\u7269\u5b66\u6d3b\u6027\u4e0e\u9776\u5411\u7ed3\u5408<\/p>\n<ul>\n<li>\u82e5\u53c2\u7167\u836f\u548c\u4e34\u5e8a\u76f8\u5173\u7684\u4f5c\u7528\u673a\u5236\u662f\u5df2\u77e5\u6216\u53ef\u9884\u6d4b\u7684\uff0c\u751f\u7269\u5b66\u6d3b\u6027\u65b9\u6cd5\u5e94\u5c3d\u53ef\u80fd\u53cd\u6620\u5176\u4f5c\u7528\u673a\u5236\u3002<\/li>\n<li>\u4e00\u822c\u5e94\u8fdb\u884c\u591a\u79cd\u751f\u7269\u5b66\u6d3b\u6027\u68c0\u6d4b\u3002\u82e5\u53c2\u7167\u836f\u6709\u591a\u91cd\u751f\u7269\u5b66\u6d3b\u6027\uff0c\u5e94\u8bbe\u8ba1\u4e00\u7cfb\u5217\u68c0\u6d4b\u65b9\u6cd5\u8bc4\u4f30\u76f8\u5173\u6d3b\u6027\u7684\u8303\u56f4\u3002<\/li>\n<li>\u5e94\u5f00\u53d1\u53d8\u5f02\u5ea6\u4f4e\u4e14\u5bf9\u751f\u7269\u5b66\u6d3b\u6027\u53d8\u5316\u654f\u611f\u7684\u5206\u6790\u65b9\u6cd5\uff0c\u4ee5\u63d0\u4f9b\u53ef\u9760\u7684\u8bc4\u4f30\u7ed3\u679c\u3002<\/li>\n<li>\u82e5\u4ea7\u54c1\u5177\u6709\u7ed3\u5408\u6d3b\u6027\uff0c\u5e94\u8fdb\u884c\u76f8\u5e94\u7684\u5206\u6790\u68c0\u6d4b\u4ee5\u8868\u5f81\u5019\u9009\u836f\u7684\u7ed3\u5408\u80fd\u529b\u3002<\/li>\n<\/ul>\n<p>\u6742\u8d28<\/p>\n<ul>\n<li>\u5e94\u5c3d\u91cf\u5bf9\u53c2\u7167\u836f\u548c\u5019\u9009\u836f\u4e2d\u7684\u4ea7\u54c1\u76f8\u5173\u6742\u8d28\u8fdb\u884c\u8868\u5f81\u3001\u9274\u5b9a\u4ee5\u53ca\u5b9a\u91cf\u7814\u7a76\u3002<\/li>\n<li>\u5e94\u5bf9\u5019\u9009\u836f\u7684\u5de5\u827a\u76f8\u5173\u6742\u8d28\u8fdb\u884c\u8bc4\u4f30\u3002<\/li>\n<li>\u82e5\u5019\u9009\u836f\u751f\u4ea7\u8fc7\u7a0b\u5f15\u5165\u4e0d\u540c\u4e8e\u53c2\u7167\u836f\u7684\u6742\u8d28\u6216\u542b\u91cf\u66f4\u9ad8\uff0c\u5219\u9700\u8fdb\u884c\u989d\u5916\u7684\u836f\u7406\/\u6bd2\u7406\u6216\u5176\u4ed6\u7814\u7a76\u3002<\/li>\n<\/ul>\n<p>\u5236\u5242<\/p>\n<ul>\n<li>\u5e94\u91c7\u7528\u63a5\u8fd1\u7ec8\u4ea7\u54c1\u7684\u5408\u9002\u4e2d\u95f4\u4f53\u8fdb\u884c\u8868\u5f81\u7814\u7a76\u3002\u4e00\u822c\u9009\u7528\u539f\u6db2\uff0c\u82e5\u539f\u6db2\u9700\u8981\u8fdb\u4e00\u6b65\u5236\u5242\u5316\u6216\u5f15\u5165\u65b0\u7269\u6599\uff0c\u5e94\u8003\u8651\u8fd9\u4e9b\u5de5\u5e8f\u7684\u5f71\u54cd;\u82e5\u67d0\u4e9b\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff0c\u5728\u539f\u6db2\u4e2d\u68c0\u6d4b\u66f4\u654f\u611f\u6216\u8be5\u8d28\u91cf\u5c5e\u6027\u5728\u5236\u5242\u5316\u8fc7\u7a0b\u4e2d\u4f1a\u53d1\u751f\u53d8\u5316\uff0c\u5219\u9700\u540c\u65f6\u5bf9\u63d0\u53d6\u7684\u86cb\u767d\u6db2\u548c\u6700\u7ec8\u5236\u5242\u8fdb\u884c\u8868\u5f81\u3002<\/li>\n<li>\u82e5\u6240\u7528\u8f85\u6599\u548c\u53c2\u7167\u836f\u4e0d\u540c\uff0c\u9700\u8981\u6709\u8f85\u6599\u5df2\u6709\u7684\u6bd2\u7406\u6570\u636e\u6216\u5019\u9009\u836f\u7684\u6bd2\u7406\u5b9e\u9a8c\u6570\u636e\u652f\u6301\u3002<\/li>\n<li>\u5e94\u5173\u6ce8\u5019\u9009\u836f\u7684\u5904\u65b9\u548c\u521d\u7ea7\u5305\u88c5\u4e0e\u53c2\u7167\u836f\u4e4b\u95f4\u7684\u5dee\u5f02\u3002<\/li>\n<\/ul>\n<p>\u7a33\u5b9a\u6027<\/p>\n<ul>\n<li>\u9664\u4e86\u8fdb\u884c\u5019\u9009\u836f\u7684\u5b9e\u65f6\u7a33\u5b9a\u6027\u4ee5\u652f\u6301\u6548\u671f\u7684\u62df\u5b9a\uff0c\u8fd8\u5e94\u8fdb\u884c\u53c2\u7167\u836f\u548c\u5019\u9009\u836f\u52a0\u901f\u3001\u5f71\u54cd\u56e0\u7d20\u53ca\u5f3a\u5236\u964d\u89e3\u7684\u6bd4\u5bf9\u7814\u7a76\uff0c\u8fd9\u4e9b\u7814\u7a76\u7684\u7ed3\u679c\u6216\u53ef\u8bc6\u522b\u51fa\u9700\u989d\u5916\u8bc4\u4f30\u7684\u5dee\u5f02\uff0c\u5e76\u5e2e\u52a9\u5efa\u7acb\u751f\u4ea7\u548c\u50a8\u5b58\u8fc7\u7a0b\u4e2d\u9700\u91c7\u53d6\u54ea\u4e9b\u989d\u5916\u7684\u63a7\u5236\u63aa\u65bd\u3002<\/li>\n<\/ul>\n<p>\u53c2\u7167\u836f\u4e0e\u53c2\u6bd4\u54c1<\/p>\n<ul>\n<li>\u6bd4\u5bf9\u7814\u7a76\u4e0d\u5e94\u4ec5\u5173\u6ce8\u5019\u9009\u836f\u7684\u8868\u5f81\u7814\u7a76\uff0c\u8fd8\u5e94\u5173\u6ce8\u53c2\u7167\u836f\u3001\u672a\u5728\u76ee\u6807\u7533\u62a5\u56fd\u5bb6\u76d1\u7ba1\u673a\u6784\u6279\u51c6\u7684\u53c2\u7167\u836f(\u82e5\u9002\u7528\uff09\u3001\u7528\u5230\u7684\u53c2\u6bd4\u54c1\u7684\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\uff0c\u5e76\u8003\u8651\u5df2\u516c\u5f00\u53d1\u8868\u7684\u76f8\u5173\u4fe1\u606f\u3002<\/li>\n<\/ul>\n<p><strong><b>\u662f\u5426\u53ef\u4ee5\u9009\u62e9\u672a\u83b7\u5f97\u76ee\u6807\u7533\u62a5\u5730\u6240\u5728\u76d1\u7ba1\u673a\u6784\u6279\u51c6\u7684\u4ea7\u54c1\u4f5c\u4e3a\u53c2\u7167\u836f\uff1f<\/b><\/strong><\/p>\n<p>1.NMPA<\/p>\n<p>\u53c2\u7167\u836f\u5e94\u9009\u62e9\u5728\u4e2d\u56fd\u4e0a\u5e02\u9500\u552e\u7684\u539f\u7814\u836f\uff0c\u7814\u53d1\u8fc7\u7a0b\u4e2d\u5404\u9636\u6bb5\u6240\u4f7f\u7528\u53c2\u7167\u836f\u5e94\u5c3d\u53ef\u80fd\u4f7f\u7528\u76f8\u540c\u4ea7\u5730\u6765\u6e90\u7684\u4ea7\u54c1\u3002\u5bf9\u4e0d\u80fd\u901a\u8fc7\u5546\u4e1a\u9014\u5f84\u5728\u4e2d\u56fd\u83b7\u5f97\u7684\uff0c\u53ef\u8003\u8651\u5176\u4ed6\u5408\u9002\u9014\u5f84\uff0c\u4f46\u5e94\u589e\u52a0\u4e0d\u540c\u6765\u6e90\u53c2\u7167\u836f\u7684\u6865\u63a5\u6bd4\u5bf9\u7814\u7a76\u6216\u63d0\u4f9b\u4e0d\u540c\u6765\u6e90\u53c2\u7167\u836f\u4e4b\u95f4\u53ef\u6bd4\u7684\u8bc1\u636e\uff0c\u540c\u65f6\u5173\u6ce8\u539f\u6db2\u6765\u6e90\u3002\u4e34\u5e8a\u8bd5\u9a8c\u7528\u53c2\u7167\u836f\u7684\u9009\u62e9\u53ca\u8981\u6c42\u53ef\u53c2\u8003\u300a\u751f\u7269\u7c7b\u4f3c\u836f\u7814\u53d1\u76f8\u5173\u95ee\u9898\u95ee\u4e0e\u7b54\u300b\u3002<sup>[18][19]<\/sup><\/p>\n<p>2.FDA &amp; EMA<\/p>\n<p>\u8fd9\u4e24\u4e2a\u76d1\u7ba1\u673a\u6784\u5bf9\u53c2\u7167\u836f\u7684\u8981\u6c42\u5927\u4f53\u76f8\u540c\u3002\u5e94\u91c7\u7528US\/\u6b27\u76df\u7ecf\u6d4e\u533a\uff08European Economic Area\uff0cEEA\uff09\u6279\u51c6\u4ea7\u54c1\u4f5c\u4e3a\u53c2\u7167\u836f\uff0c\u82e5\u5728\u67d0\u4e9b\u7814\u7a76\u4e2d\u9700\u7528\u5230\u975eUS\/EEA\u6279\u51c6\u7684\u4ea7\u54c1\u4f5c\u4e3a\u5bf9\u7167\u65f6\uff0c\u5e94\u63d0\u4f9b\u8db3\u591f\u7684\u6570\u636e\/\u4fe1\u606f\u5e76\u548c\u5f53\u5730\u76d1\u7ba1\u673a\u6784\u6279\u51c6\u7684\u4ea7\u54c1\u8fdb\u884c\u5408\u7406\u6865\u63a5\uff0c\u5982\u5019\u9009\u836f\u3001\u975eUS\/EEA\u6279\u51c6\u4ea7\u54c1\u3001US\/EEA \u6279\u51c6\u4ea7\u54c1\u4e09\u8005\u7684\u5bf9\u6bd4\uff0c\u53ef\u80fd\u8fd8\u5305\u62ec\u4e34\u5e8a\u836f\u4ee3\u52a8\u529b\u5b66\uff08Pharmacokinetic\uff0cPK\uff09\u7814\u7a76\u548c\/\u6216\u836f\u6548\u5b66\uff08pharmacodynamics\uff0cPD\uff09\u7684\u6865\u63a5\u7814\u7a76\u3002\u5efa\u8bae\u63d0\u524d\u548c\u76d1\u7ba1\u673a\u6784\u5c31\u6b64\u95ee\u9898\u8fdb\u884c\u8ba8\u8bba\u3002<sup>[2][7][12]<\/sup><\/p>\n<p><strong><b>\u751f\u7269\u7c7b\u4f3c\u836f\u8fdb\u884c\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\u65f6\u9700\u7eb3\u5165\u591a\u5c11\u6279\u6b21\u7684\u53c2\u7167\u836f\u53ca\u5019\u9009\u836f\uff1f<\/b><\/strong><\/p>\n<p>1.NMPA<\/p>\n<p>\u8003\u8651\u5230\u751f\u7269\u5236\u54c1\u7ed3\u6784\u7684\u5f02\u8d28\u6027\u548c\u6279\u95f4\u53d8\u5f02\u6027\uff0c\u6bd4\u5bf9\u7814\u7a76\u5e94\u7eb3\u5165\u8db3\u591f\u4ee3\u8868\u6027\u6279\u6b21\u7684\u53c2\u7167\u836f\u5efa\u7acb\u76f8\u4f3c\u6027\u8bc4\u4ef7\u53ef\u63a5\u53d7\u8303\u56f4\uff0c\u6279\u6b21\u6570\u91cf\u7684\u8981\u6c42\u53d6\u51b3\u4e8e\u8d28\u91cf\u5c5e\u6027\u548c\u5206\u6790\u65b9\u6cd5\u7684\u53d8\u5f02\u7a0b\u5ea6\uff0c\u5e94\u80fd\u5bf9\u5019\u9009\u836f\u548c\u53c2\u7167\u836f\u7684\u8d28\u91cf\u76f8\u4f3c\u6027\u8fdb\u884c\u6709\u610f\u4e49\u7684\u6bd4\u8f83\u3002\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\u6240\u4f7f\u7528\u7684\u5019\u9009\u836f\uff0c\u5e94\u5c3d\u53ef\u80fd\u9009\u62e9\u5546\u4e1a\u5316\u751f\u4ea7\u4ee3\u8868\u6027\u5de5\u827a\u6761\u4ef6\u5236\u5907\u7684\u6279\u6b21\u3002\u901a\u5e38\u4e34\u5e8a\u7814\u7a76\u6279\u6b21\u548c\u5546\u4e1a\u5316\u5de5\u827a\u9a8c\u8bc1\u6279\u6b21\u5e94\u7eb3\u5165\u8fdb\u884c\u6bd4\u5bf9\u7814\u7a76\u3002\u5bf9\u4e8e\u6bd4\u5bf9\u7814\u7a76\u9009\u62e9\u4e0d\u540c\u5f00\u53d1\u9636\u6bb5\u5019\u9009\u836f\u7684\uff0c\u5e94\u5145\u5206\u8bc4\u4f30\u4ea7\u54c1\u5f00\u53d1\u671f\u95f4\u836f\u5b66\u53d8\u66f4\uff08\u5982\u6709\uff09\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\u3002\u6bd4\u5bf9\u7814\u7a76\u7528\u5019\u9009\u836f\u5236\u5242\u5e94\u5c3d\u53ef\u80fd\u6765\u6e90\u4e8e\u4e0d\u540c\u7684\u539f\u6db2\u6279\u6b21\uff0c\u4ee5\u5145\u5206\u4f53\u73b0\u4ea7\u54c1\u6279\u95f4\u53d8\u5f02\u6027\u3002<\/p>\n<p>2.FDA<\/p>\n<p>\u5efa\u8bae\u7eb3\u5165\u81f3\u5c1110\u6279\u53c2\u7167\u836f\uff08\u5931\u6548\u671f\u8de8\u8d8a\u6570\u5e74\uff09\u4e0e\u81f3\u5c116-10\u6279\u5019\u9009\u836f\uff08\u9700\u6db5\u76d6\u4e34\u5e8a\u8bd5\u9a8c\u548c\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u6279\u6b21\uff09\u8fdb\u884c\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\uff0c\u4ee5\u786e\u4fdd\u5145\u5206\u53cd\u6620\u53c2\u7167\u836f\u7684\u53d8\u5f02\u6027\u3001\u7406\u89e3\u548c\u8bc4\u4f30\u5019\u9009\u836f\u7684\u6279\u95f4\u5dee\u5f02\uff0c\u5e76\u548c\u53c2\u7167\u836f\u8fdb\u884c\u5145\u5206\u6bd4\u5bf9\u3002\u5f53\u53c2\u7167\u836f\u7684\u6279\u6b21\u6570\u91cf\u6709\u9650\u65f6\uff08\u4f8b\u5982\u5b64\u513f\u836f\uff09\uff0c\u5e94\u63d0\u4f9b\u5176\u4ed6\u66ff\u4ee3\u7684\u836f\u5b66\u6bd4\u5bf9\u7814\u7a76\u65b9\u6848\uff0c\u5e76\u4e0e\u76d1\u7ba1\u673a\u6784\u8fdb\u884c\u6c9f\u901a\u3002<sup>[2]<\/sup><\/p>\n<p>3.EMA<\/p>\n<p>\u5e94\u7eb3\u5165\u591a\u4e2a\u4e0d\u540c\u6279\u6b21\u7684\u53c2\u7167\u836f\u4ee5\u63d0\u4f9b\u53ef\u9760\u7684\u6bd4\u5bf9\u7814\u7a76\u6570\u636e\uff0c\u8fdb\u800c\u83b7\u5f97\u5177\u6709\u4ee3\u8868\u6027\u7684\u76ee\u6807\u8d28\u91cf\u6982\u51b5\u3002\u5728\u5efa\u7acb\u76ee\u6807\u8d28\u91cf\u6982\u51b5\u65f6\uff0c\u8fd8\u5e94\u8003\u8651\u4e0d\u540c\u6279\u6b21\u53c2\u7167\u836f\u7684\u6548\u671f\u95ee\u9898\u3002<sup>[10]<\/sup><\/p>\n<p><strong><b>\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u548c\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u7684\u7533\u62a5\u9014\u5f84\u53ca\u5ba1\u8bc4\u65f6\u9650\u662f\u600e\u6837\u7684\uff1f<\/b><\/strong><\/p>\n<p>1.NMPA<\/p>\n<p>\u6309\u65b0\u836f\u7533\u8bf7\u7684\u7a0b\u5e8f\u7533\u62a5\uff0c\u6ce8\u518c\u5206\u7c7b\u4e3a3.3\u7c7b\uff08\u751f\u7269\u7c7b\u4f3c\u836f\uff09\uff0c\u5ba1\u8bc4\u65f6\u9650\u4ea6\u548c\u65b0\u836f\u76f8\u540c\uff1a\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u7684\u5ba1\u8bc4\u65f6\u9650\u4e00\u822c\u4e3a60\u4e2a\u5de5\u4f5c\u65e5\uff0c\u4e0a\u5e02\u7533\u8bf7\u7684\u5ba1\u8bc4\u65f6\u9650\u4e00\u822c\u4e3a200\u4e2a\u5de5\u4f5c\u65e5\uff0c\u5177\u4f53\u5ba1\u8bc4\u65f6\u9650\u89c4\u5b9a\u53ef\u53c2\u8003\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u3002<sup>[16][17]<\/sup><\/p>\n<p>2.FDA<\/p>\n<p>\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u7684\u6280\u672f\u5ba1\u8bc4\u65f6\u9650\u4e00\u822c\u4e3a30\u4e2a\u65e5\u5386\u65e5\uff1b\u4e0a\u5e02\u7533\u8bf7\u7684\u6ce8\u518c\u9014\u5f84\u548c\u65b0\u836f\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u4e0d\u540c\uff0c\u5206\u522b\u8d70351(k)\u548c351(a)\u8def\u5f84\uff0c\u4f46\u5ba1\u8bc4\u65f6\u9650\u548c\u65b0\u836f\u76f8\u540c\uff1a90%\u7684\u7533\u8bf7\u5c06\u5728\u53d7\u7406\u540e\u768410\u4e2a\u6708\u5185\u5b8c\u6210\u3002\u00a0<sup>[3][8]<\/sup><\/p>\n<p>3.EMA<\/p>\n<p>\u548c\u65b0\u836f\u4e00\u6837\uff0c\u751f\u7269\u7c7b\u4f3c\u836f\u9700\u9012\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08CTA\uff09\u3001\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u3002CTA\u7684\u6280\u672f\u5ba1\u8bc4\u65f6\u9650\u4e00\u822c\u4e3a45\u4e2a\u65e5\u5386\u65e5\uff08\u751f\u7269\u6280\u672f\u5236\u54c1\u53ca\u5148\u8fdb\u7597\u6cd5\u53ef\u80fd\u989d\u5916\u5ef6\u957f50\u4e2a\u65e5\u5386\u65e5\uff09\u3002\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7edd\u5927\u90e8\u5206\u662f\u901a\u8fc7\u96c6\u4e2d\u5ba1\u6279\u7a0b\u5e8f\u83b7\u6279\u7684\uff0c\u5176\u6280\u672f\u5ba1\u8bc4\u65f6\u9650\u4e00\u822c\u4e3a210\u4e2a\u65e5\u5386\u65e5\uff0c\u8be6\u7ec6\u7684\u5ba1\u8bc4\u65f6\u95f4\u8868\u53ef\u53c2\u8003\u6307\u5357\u539f\u6587\u3002<sup>[13][14]<\/sup><\/p>\n<p><strong><b>\u5982\u4f55\u67e5\u8be2\u5df2\u83b7\u6279\u7684\u751f\u7269\u7c7b\u4f3c\u836f\uff1f<\/b><\/strong><\/p>\n<p>1.NMPA<\/p>\n<p>\u622a\u81f32024\u5e745\u670813\u65e5\uff0cNMPA\u5df2\u6279\u51c642\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\uff08\u5bf9\u5e9412\u4e2a\u53c2\u7167\u836f\uff09\uff0c\u53ef\u5728\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6570\u636e\u67e5\u8be2\uff08nmpa.gov.cn\uff09\u7f51\u7ad9\u901a\u8fc7\u4ea7\u54c1\u540d\u79f0\u67e5\u8be2\u76f8\u5173\u6279\u51c6\u4fe1\u606f\u3002<\/p>\n<p>2.FDA<\/p>\n<p>\u622a\u81f32024\u5e744\u670825\u65e5\uff0cFDA\u5df2\u6279\u51c650\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\uff08\u5bf9\u5e9415\u4e2a\u53c2\u7167\u836f\uff09\uff0c\u8be6\u89c1Biosimilar Product Information | FDA\u3002<\/p>\n<p>3.EMA<\/p>\n<p>\u622a\u81f32024\u5e743\u67087\u65e5\uff0cEMA\u5df2\u6279\u51c682\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\uff08\u4ec5\u7edf\u8ba1\u901a\u8fc7\u96c6\u4e2d\u5ba1\u6279\u7a0b\u5e8f\u83b7\u6279\u4ea7\u54c1\uff0c\u5bf9\u5e9423\u4e2a\u53c2\u7167\u836f\uff09\uff0c\u8be6\u89c1Search | European Medicines Agency (europa.eu)\u3002<\/p>\n<p><strong><b>\u9002\u5e94\u75c7\u5916\u63a8\u9700\u6ee1\u8db3\u4ec0\u4e48\u6761\u4ef6\uff1f<\/b><\/strong><\/p>\n<p>1.NMPA<\/p>\n<p>\u6bd4\u5bf9\u8bd5\u9a8c\u8bc1\u5b9e\u4e34\u5e8a\u76f8\u4f3c\u65f6\u53ef\u8003\u8651\u9002\u5e94\u75c7\u5916\u63a8\u3002\u5bf9\u5916\u63a8\u7684\u9002\u5e94\u75c7\uff0c\u5e94\u662f\u4e34\u5e8a\u76f8\u5173\u7684\u75c5\u7406\u673a\u5236\u548c\/\u6216\u6709\u5173\u53d7\u4f53\u76f8\u540c\uff0c\u4e14\u4f5c\u7528\u673a\u7406\u4ee5\u53ca\u9776\u70b9\u76f8\u540c\u7684\uff1b\u4e34\u5e8a\u6bd4\u5bf9\u8bd5\u9a8c\u4e2d\uff0c\u9009\u62e9\u4e86\u5408\u9002\u7684\u9002\u5e94\u75c7\uff0c\u5e76\u5bf9\u5916\u63a8\u9002\u5e94\u75c7\u7684\u5b89\u5168\u6027\u548c\u514d\u75ab\u539f\u6027\u8fdb\u884c\u4e86\u5145\u5206\u7684\u8bc4\u4f30\u3002\u9002\u5e94\u75c7\u5916\u63a8\u9700\u6839\u636e\u4ea7\u54c1\u7279\u70b9\u4e2a\u6848\u5316\u8003\u8651\u3002\u5bf9\u5408\u5e76\u7528\u836f\u4eba\u7fa4\u3001\u4e0d\u540c\u5408\u5e76\u75be\u75c5\u4eba\u7fa4\u53ca\u5b58\u5728\u4e0d\u540c\u63a8\u8350\u5242\u91cf\u7b49\u60c5\u5f62\u8fdb\u884c\u9002\u5e94\u75c7\u5916\u63a8\u65f6\u5e94\u614e\u91cd\u3002<sup>[16]<\/sup><\/p>\n<p>2.FDA<\/p>\n<p>\u9700\u5728\u4e0a\u5e02\u7533\u8bf7\u4e2d\u63d0\u4f9b\u5145\u5206\u7684\u89e3\u91ca\uff0c\u5305\u62ec\u7528\u4e8e\u6bcf\u79cd\u9002\u5e94\u75c7\u7684\u4f5c\u7528\u673a\u5236\uff1b\u5728\u4e0d\u540c\u60a3\u8005\u7fa4\u4f53\u4e2d\u7684PK\u3001PD\u6570\u636e\uff1b\u4e0d\u540c\u60a3\u8005\u7fa4\u4f53\u4e2d\u7684\u514d\u75ab\u539f\u6027\uff1b\u6bcf\u79cd\u9002\u5e94\u75c7\u548c\u60a3\u8005\u7fa4\u4f53\u4e2d\u7684\u9884\u671f\u6bd2\u6027\u5dee\u5f02\uff1b\u4efb\u4f55\u5f71\u54cd\u4ea7\u54c1\u5728\u6bcf\u4e2a\u9002\u5e94\u75c7\u53ca\u60a3\u8005\u7fa4\u4f53\u4e2d\u7684\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u7684\u56e0\u7d20\u3002<sup>[5]<\/sup><\/p>\n<p>3.EMA<\/p>\n<p>\u5e94\u7ed3\u5408\u836f\u5b66\u3001\u975e\u4e34\u5e8a\u3001\u4e34\u5e8a\u7684\u6574\u4f53\u6570\u636e\u6765\u8003\u8651\u9002\u5e94\u75c7\u7684\u5916\u63a8\u3002\u5f53\u5168\u9762\u7684\u7406\u5316\u3001\u7ed3\u6784\u5206\u6790\u3001\u4f53\u5916\u529f\u80fd\u6d4b\u8bd5\u4ee5\u53ca\u5728\u67d0\u4e2a\u9002\u5e94\u75c7\u4e2d\u7684\u4e34\u5e8a\u6570\u636e\uff08\u6709\u6548\u6027\u5b89\u5168\u6027\u548c\/\u6216PK\u3001PD\u6570\u636e\uff09\u53ef\u8bc1\u660e\u5019\u9009\u836f\u4e0e\u53c2\u7167\u836f\u7684\u751f\u7269\u76f8\u4f3c\u6027\u65f6\uff0c\u53ef\u8003\u8651\u5019\u9009\u836f\u7269\u6709\u6548\u6027\u3001\u5b89\u5168\u6027\u7684\u5916\u63a8\u3002\u4f46\u67d0\u4e9b\u60c5\u51b5\u4e0b\u53ef\u80fd\u8fd8\u9700\u989d\u5916\u7684\u6570\u636e\u652f\u6301\uff0c\u5982\u53c2\u7167\u836f\u7684\u6d3b\u6027\u6210\u5206\u548c\u591a\u79cd\u53d7\u4f53\u6709\u76f8\u4e92\u4f5c\u7528\u3001\u6d3b\u6027\u6210\u5206\u672c\u8eab\u5177\u6709\u591a\u4e2a\u6d3b\u6027\u4f4d\u70b9\u4e14\u5bf9\u4e0d\u540c\u9002\u5e94\u75c7\u53ef\u80fd\u6709\u4e0d\u540c\u5f71\u54cd\u3001\u4e0d\u540c\u9002\u5e94\u75c7\u5bf9\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u5dee\u5f02\u4e0d\u654f\u611f\u7b49\u3002\u514d\u75ab\u539f\u6027\u56e0\u5176\u4e0e\u7ed9\u836f\u9014\u5f84\u548c\u65b9\u6848\u3001\u60a3\u8005\u672c\u8eab\u53ca\u5176\u75c5\u75c7\u56e0\u7d20\u5747\u6709\u5173\uff0c\u56e0\u6b64\u4ece\u5df2\u7814\u7a76\u7684\u9002\u5e94\u75c7\/\u7ed9\u836f\u9014\u5f84\u5916\u63a8\u81f3\u8be5\u836f\u7269\u7684\u5176\u4ed6\u4f7f\u7528\u65b9\u5f0f\u65f6\u9700\u8fdb\u884c\u5408\u7406\u8bba\u8bc1\u3002<sup>[11]<\/sup><\/p>\n<p><strong><b>\u6cd5\u89c4\u901f\u9012<\/b><\/strong><\/p>\n<p><strong><b>FDA\uff1a<\/b><\/strong><\/p>\n<ol>\n<li><b><\/b>Review and Approval | FDA \u2013Regulatory and Scientific Concepts<\/li>\n<li><b><\/b>Development of Therapeutic Protein Biosimilars:Comparative Analytical Assessment and Other Quality Related Considerations<\/li>\n<li><b><\/b>BsUFA III Commitment Letter<\/li>\n<li><b><\/b>Biosimilars Action Plan<\/li>\n<li><b><\/b>Scientific Considerations in Demonstrating Biosimilarity to a Reference Product<\/li>\n<li><b><\/b>Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants<\/li>\n<li><b><\/b>Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product<\/li>\n<li><b><\/b>IND Application Procedures: Overview<\/li>\n<\/ol>\n<p><strong><b>EMA\uff1a<\/b><\/strong><\/p>\n<ol start=\"9\">\n<li><b><\/b>Biosimilar medicines: Overview | European Medicines Agency (europa.eu)<\/li>\n<li><b><\/b>Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)<\/li>\n<li><b><\/b>Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues<\/li>\n<li><b><\/b>Guideline on similar biological medicinal products<\/li>\n<li><b><\/b>Regulation (EU) No 536\/2014<\/li>\n<li><b><\/b>European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications<\/li>\n<\/ol>\n<p><strong><b>NMPA\uff1a<\/b><\/strong><\/p>\n<ol 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