\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff0910\u670829\u65e5\uff08\u5468\u4e09\uff09\u5ba3\u5e03\uff0c\u5c06\u91c7\u53d6\u63aa\u65bd\u7b80\u5316\u590d\u6742\u751f\u7269\u836f\u7269\u4eff\u5236\u836f\u7684\u7814\u53d1\u6d41\u7a0b\u3002\u6b64\u4e3e\u65e8\u5728\u52a0\u5feb\u4ef7\u683c\u66f4\u4f4e\u7684\u66ff\u4ee3\u836f\u7269\u83b7\u6279\u8fdb\u7a0b\uff0c\u4ece\u800c\u589e\u52a0\u5e02\u573a\u7ade\u4e89\uff0c\u964d\u4f4e\u7f8e\u56fd\u4eba\u7684\u7528\u836f\u6210\u672c\u3002\u751f\u7269\u836f\u7269\u4f7f\u7528\u6d3b\u4f53\u6765\u6e90\uff08\u5982\u7ec6\u83cc\u3001\u9175\u6bcd\u548c\u52a8\u7269\u7ec6\u80de\uff09\u7814\u53d1\u800c\u6210\uff0c\u56e0\u6b64\u6bd4\u5316\u5b66\u5408\u6210\u836f\u7269\u7684\u751f\u4ea7\u66f4\u5177\u590d\u6742\u6027\u4e0e\u53d8\u5f02\u6027\u3002\u751f\u7269\u836f\u7269\u6709\u72ec\u7acb\u7684FDA\u5ba1\u6279\u901a\u9053\uff0c\u800c\u201c\u751f\u7269\u7c7b\u4f3c\u836f\u201d\uff08biosimilars\uff0c\u5373\u54c1\u724c\u836f\u7684\u4eff\u5236\u7248\u672c\uff09\u957f\u671f\u4ee5\u6765\u4e5f\u4e0e\u666e\u901a\u4eff\u5236\u836f\u533a\u522b\u5bf9\u5f85\u3002<\/p>\n
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\u4f5c\u4e3a\u6b64\u6b21\u516c\u544a\u7684\u4e00\u90e8\u5206\uff0cFDA\u53d1\u5e03\u4e86\u65b0\u7684\u6307\u5bfc\u8349\u6848\uff0c\u5efa\u8bae\u5141\u8bb8\u4f01\u4e1a\u51cf\u5c11\u8bc1\u660e\u5176\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u5df2\u6279\u51c6\u539f\u7814\u836f\u201c\u8db3\u591f\u76f8\u4f3c\u201d\u6240\u9700\u7684\u7814\u7a76\u4e0e\u8bd5\u9a8c\u6570\u91cf\u3002FDA\u5c40\u957f\u9a6c\u8482\u00b7\u9a6c\u5361\u91cc\uff08Dr. Marty Makary\uff09\u5728\u58f0\u660e\u4e2d\u8868\u793a\uff1a\u201c\u751f\u7269\u7c7b\u4f3c\u836f\u901a\u5e38\u5bf9\u60a3\u8005\u6765\u8bf4\u66f4\u5b9e\u60e0\uff0c\u4e14\u6709\u6f5c\u529b\u663e\u8457\u964d\u4f4e\u7f8e\u56fd\u7684\u533b\u7597\u652f\u51fa\u3002\u901a\u8fc7\u7cbe\u7b80\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u5f00\u53d1\u6d41\u7a0b\u5e76\u63a8\u52a8\u5176\u53ef\u4e92\u6362\u6027\uff0c\u6211\u4eec\u80fd\u591f\u5927\u5e45\u964d\u4f4e\u764c\u75c7\u3001\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u53ca\u7f55\u89c1\u75c5\u7b49\u5148\u8fdb\u7597\u6cd5\u7684\u6210\u672c\u3002\u201d<\/p>\n
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\u6839\u636eFDA\u6570\u636e\uff0c\u751f\u7269\u836f\u4ec5\u5360\u7f8e\u56fd\u5904\u65b9\u836f\u76845%\uff0c\u4f46\u5374\u5360\u603b\u836f\u54c1\u652f\u51fa\u7684\u8fc7\u534a\u3002\u622a\u81f310\u6708\u521d\uff0cFDA\u4ec5\u6279\u51c6\u4e8676\u79cd\u751f\u7269\u7c7b\u4f3c\u836f\uff0c\u800c\u672a\u6765\u5341\u5e74\u5c06\u5931\u53bb\u4e13\u5229\u4fdd\u62a4\u7684\u751f\u7269\u836f\u4e2d\uff0c\u76ee\u524d\u53ea\u6709\u7ea6\u5341\u5206\u4e4b\u4e00\u5df2\u6709\u751f\u7269\u7c7b\u4f3c\u836f\u5728\u5f00\u53d1\u4e2d\u3002\u9a6c\u5361\u91cc\u5728\u65b0\u95fb\u53d1\u5e03\u4f1a\u4e0a\u8868\u793a\uff0c\u65b0\u89c4\u5c06\u5e2e\u52a9\u5236\u836f\u516c\u53f8\u5c06\u751f\u7269\u7c7b\u4f3c\u836f\u4e0a\u5e02\u65f6\u95f4\u7f29\u77ed\u4e00\u534a\uff0c\u5e76\u53ef\u8282\u7701\u7ea61\u4ebf\u7f8e\u5143\u7684\u5f00\u53d1\u6210\u672c\u3002\u4ed6\u6307\u51fa\uff1a\u201c\u7f8e\u56fd\u533b\u7597\u652f\u51fa\u589e\u957f\u6700\u5feb\u7684\u9886\u57df\u662f\u836f\u54c1\u652f\u51fa\uff0c\u800c\u5176\u4e2d\u589e\u901f\u6700\u5feb\u7684\u7c7b\u522b\u6b63\u662f\u8fd9\u4e00\u7c7b\u65b0\u578b\u836f\u7269\u2014\u2014\u751f\u7269\u836f\u3002\u836f\u7269\u7814\u53d1\u6210\u672c\u964d\u4f4e\u610f\u5473\u7740\u7814\u53d1\u652f\u51fa\u51cf\u5c11\uff0c\u6700\u7ec8\u4e5f\u4f1a\u5e26\u6765\u836f\u4ef7\u4e0b\u964d\u3002\u201d<\/p>\n
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\u7f8e\u56fd\u9996\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\u4e8e2015\u5e74\u83b7\u6279\u3002FDA\u5206\u6790\u8fc7\u53bb\u5341\u5e74\u7684\u6570\u636e\u540e\u6307\u51fa\uff0c\u76f4\u63a5\u6bd4\u8f83\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u53c2\u8003\u836f\u4e34\u5e8a\u7597\u6548\u7684\u7814\u7a76\uff0c\u5bf9\u9a8c\u8bc1\u4e24\u8005\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u7684\u5dee\u5f02\u201c\u5728\u79d1\u5b66\u4e0a\u589e\u52a0\u7684\u4ef7\u503c\u6709\u9650\uff0c\u76f8\u6bd4\u4e4b\u4e0b\u5206\u6790\u68c0\u6d4b\u7684\u4ef7\u503c\u66f4\u5927\u201d\u3002\u56e0\u6b64\uff0c\u65b0\u6307\u5357\u201c\u51cf\u5c11\u4e86\u5f00\u53d1\u5546\u5fc5\u987b\u8fdb\u884c\u7684\u4eba\u4f53\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u8fd9\u4e00\u8017\u65f6\u4e14\u9ad8\u6210\u672c\u7684\u8981\u6c42\u201d\uff0c\u5141\u8bb8\u4f01\u4e1a\u201c\u4e3b\u8981\u901a\u8fc7\u5206\u6790\u68c0\u6d4b\u6765\u8bc1\u660e\u4ea7\u54c1\u5dee\u5f02\u201d\u3002\u4ee5Humira\u4e3a\u4f8b\uff0c\u8fd9\u662f\u4e00\u79cd\u7528\u4e8e\u6cbb\u7597\u591a\u79cd\u81ea\u8eab\u514d\u75ab\u75be\u75c5\uff08\u5305\u62ec\u7c7b\u98ce\u6e7f\u6027\u5173\u8282\u708e\uff09\u7684\u6ce8\u5c04\u578b\u751f\u7269\u836f\uff0c\u81ea2002\u5e74\u83b7\u6279\u4ee5\u6765\u957f\u671f\u4f4d\u5217\u5168\u7403\u836f\u54c1\u9500\u552e\u699c\u524d\u5217\u3002\u81ea2016\u5e74\u4ee5\u6765\u5df2\u670910\u6b3eHumira\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u83b7\u6279\uff0c\u4f46\u76f4\u52302023\u5e74\u624d\u6709\u9996\u6b3e\u771f\u6b63\u4e0a\u5e02\u3002\u9a6c\u5361\u91cc\u8868\u793a\uff1a\u201c\u533b\u7597\u4f53\u7cfb\u7684\u6839\u672c\u95ee\u9898\u5728\u4e8e\u7f3a\u4e4f\u7ade\u4e89\u3002\u5f53\u7ade\u4e89\u7f3a\u5931\uff0c\u5c31\u4f1a\u5bfc\u81f4\u957f\u671f\u5784\u65ad\u3002\u6211\u4eec\u5e0c\u671b\u770b\u5230\u66f4\u591a\u7ade\u4e89\u4e0e\u521b\u65b0\u3002\u201d<\/p>\n
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Truveta Research\u57286\u6708\u7684\u4e00\u9879\u7814\u7a76\u5206\u6790\u4e86\u8fd16.7\u4e07\u540dHumira\u4f7f\u7528\u8005\u7684\u5904\u65b9\u8d8b\u52bf\uff0c\u7ed3\u679c\u53d1\u73b0\uff0c\u4ece2023\u5e741\u6708\u81f32025\u5e744\u6708\uff0c\u5927\u7ea613%\u7684\u60a3\u8005\u8f6c\u5411\u4e86\u751f\u7269\u7c7b\u4f3c\u836f\uff0c\u4f46\u5176\u4e2d\u7ea613%\u53c8\u91cd\u65b0\u6362\u56deHumira\u3002\u7814\u7a76\u6307\u51fa\uff1a\u201c\u4e5f\u5c31\u662f\u8bf4\uff0c\u6bcf100\u4f4dHumira\u60a3\u8005\u4e2d\uff0c\u670913\u4f4d\u8f6c\u7528\u751f\u7269\u7c7b\u4f3c\u836f\uff0c\u800c\u5176\u4e2d2\u4f4d\u53c8\u6362\u56de\u539f\u836f\u3002\u201druveta\u7814\u7a76\u56e2\u961f\u8ba4\u4e3a\uff0c\u8fd9\u4e00\u53d8\u5316\u53ef\u80fd\u53cd\u6620\u4e86\u4fdd\u9669\u653f\u7b56\u7684\u8c03\u6574\u3001\u533b\u60a3\u5bf9\u751f\u7269\u7c7b\u4f3c\u836f\u4fe1\u4efb\u5ea6\u7684\u63d0\u5347\u6216\u836f\u54c1\u5e02\u573a\u7684\u6574\u4f53\u53d8\u5316\uff0c\u4f46\u201c\u521d\u6b21\u8f6c\u6362\u5e76\u4e0d\u603b\u80fd\u6301\u7eed\uff0c\u5373\u4f7f\u4ef7\u683c\u66f4\u4f4e\u201d\u3002\u7814\u7a76\u8fd8\u6307\u51fa\uff0c\u201c\u8fd140%\u91cd\u65b0\u4f7f\u7528Humira\u7684\u60a3\u8005\u5728\u4f7f\u7528\u751f\u7269\u7c7b\u4f3c\u836f30\u5929\u5185\u5c31\u6362\u56de\uff0c\u53ef\u80fd\u53cd\u6620\u4e86\u65e9\u671f\u4e0d\u9002\u6216\u526f\u4f5c\u7528\u3002\u8bb8\u591a\u60a3\u8005\u5728\u5b8c\u6210\u4e00\u8f6eHumira\u5904\u65b9\u4e4b\u524d\u5c31\u5207\u6362\u56de\u53bb\uff0c\u4e5f\u53ef\u80fd\u53cd\u6620\u51fa\u5bf9\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e0d\u5b89\u6216\u4e0d\u786e\u5b9a\u611f\u3002\u201d<\/p>\n
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\u7531\u4e8e\u751f\u7269\u7c7b\u4f3c\u836f\u5e76\u975e\u5b8c\u5168\u7b49\u540c\u4e8e\u539f\u7814\u836f\uff0c\u56e0\u6b64\u82e5\u8981\u88ab\u5f52\u7c7b\u4e3a\u201c\u53ef\u4e92\u6362\u836f\u7269\u201d\uff08interchangeable\uff09\uff0c\u8fd8\u9700\u989d\u5916\u5ba1\u6279\u2014\u2014\u83b7\u5f97\u8be5\u8d44\u683c\u540e\u836f\u5e08\u53ef\u5728\u65e0\u9700\u533b\u751f\u6279\u51c6\u7684\u60c5\u51b5\u4e0b\u66ff\u6362\u4f7f\u7528\u3002FDA10\u670829\u65e5\uff08\u5468\u4e09\uff09\u8868\u793a\uff0c\u5c06\u540c\u65f6\u6d88\u9664\u90e8\u5206\u76d1\u7ba1\u969c\u788d\uff0c\u901a\u5e38\u4e0d\u518d\u5efa\u8bae\u5f00\u53d1\u5546\u8fdb\u884c\u6240\u8c13\u201c\u5207\u6362\u7814\u7a76\u201d\uff08switching studies\uff09\uff0c\u4ee5\u7b80\u5316\u83b7\u5f97\u201c\u53ef\u4e92\u6362\u201d\u8d44\u683c\u7684\u6d41\u7a0b\u3002FDA\u836f\u54c1\u8bc4\u4f30\u4e0e\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efb\u4e54\u6cbb\u00b7\u63d0\u5fb7\u9a6c\u4ec0\u535a\u58eb\uff08Dr. George Tidmarsh\uff09\u8868\u793a\uff1a\u201c\u79d1\u5b66\u5728\u4e0d\u65ad\u8fdb\u6b65\uff0cFDA\u5c06\u6301\u7eed\u63a8\u8fdb\u5e38\u8bc6\u6027\u653f\u7b56\uff0c\u786e\u4fdd\u5728\u4e0d\u727a\u7272\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u524d\u63d0\u4e0b\uff0c\u4fc3\u8fdb\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u53ef\u4e92\u6362\u836f\u7684\u9ad8\u6548\u5f00\u53d1\u3002\u201d<\/p>\n
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\u4eff\u5236\u836f\u4e0e\u751f\u7269\u7c7b\u4f3c\u836f\u5236\u9020\u5546\u534f\u4f1a\uff08AAM\uff09\u4e3b\u5e2d\u517c\u9996\u5e2d\u6267\u884c\u5b98\u7ea6\u7ff0\u00b7\u58a8\u83f2\uff08John Murphy\uff09\u8868\u793a\uff0cFDA\u7684\u65b0\u6307\u5357\u53ef\u80fd\u5f88\u5feb\u4ea7\u751f\u5f71\u54cd\uff1a\u201c\u6211\u8ba4\u4e3a\u4e34\u5e8a\u7814\u53d1\u4e0e\u6295\u8d44\u51b3\u7b56\u5c06\u8fc5\u901f\u4f5c\u51fa\u3002\u867d\u7136\u836f\u7269\u5f00\u53d1\u4ecd\u9700\u65f6\u95f4\uff0c\u4f46\u672a\u6765\u4e09\u5230\u516d\u4e2a\u6708\u5185\u6211\u4eec\u53ef\u80fd\u5c31\u4f1a\u770b\u5230\u7814\u53d1\u7ba1\u7ebf\u7b56\u7565\u7684\u660e\u663e\u53d8\u5316\u3002\u201d\u4ed6\u8865\u5145\u8bf4\uff0c\u66f4\u4f4e\u7684\u5f00\u53d1\u6210\u672c\u8fd8\u53ef\u80fd\u9f13\u52b1\u5236\u836f\u516c\u53f8\u6269\u5c55\u81f3\u9488\u5bf9\u5c0f\u4f17\u60a3\u8005\u7fa4\u4f53\u7684\u751f\u7269\u836f\u9886\u57df\u3002<\/p>\n
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\u4e0d\u8fc7\u4e13\u5bb6\u6307\u51fa\uff0c\u4ecd\u9700\u786e\u4fdd\u4fdd\u9669\u653f\u7b56\u4e0e\u533b\u7597\u652f\u4ed8\u4f53\u7cfb\u771f\u6b63\u652f\u6301\u751f\u7269\u7c7b\u4f3c\u836f\u6295\u8d44\u5e76\u5f62\u6210\u5e02\u573a\u7ade\u4e89\u3002\u7f8e\u56fd\u836f\u54c1\u7814\u7a76\u4e0e\u5236\u9020\u5546\u534f\u4f1a\uff08PhRMA\uff09\u516c\u5171\u4e8b\u52a1\u9ad8\u7ea7\u526f\u603b\u88c1\u4e9a\u5386\u514b\u65af\u00b7\u65bd\u8d56\u5f17\uff08Alex Schriver\uff09\u8868\u793a\uff1a\u201c\u6211\u4eec\u6b22\u8fce\u653f\u5e9c\u5173\u6ce8\u63d0\u5347\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u53ef\u53ca\u6027\u4e0e\u53ef\u8d1f\u62c5\u6027\u3002\u653f\u7b56\u5236\u5b9a\u8005\u5fc5\u987b\u4fee\u590d\u4e2d\u95f4\u5546\u4eba\u4e3a\u963b\u788d\u751f\u7269\u7c7b\u4f3c\u836f\u3001\u725f\u5229\u4e8e\u60a3\u8005\u4e4b\u4e0a\u7684\u4e0d\u5408\u7406\u6fc0\u52b1\u673a\u5236\u3002\u201d<\/p>\n
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