{"id":33375,"date":"2019-01-16T00:20:19","date_gmt":"2019-01-15T16:20:19","guid":{"rendered":"https:\/\/case.ntu.edu.tw\/blog\/?p=33375"},"modified":"2019-01-11T09:07:26","modified_gmt":"2019-01-11T01:07:26","slug":"%e3%80%8c%e7%94%9f%e7%89%a9%e7%9b%b8%e4%bc%bc%e8%97%a5%e3%80%8d%e6%88%96%e8%a8%b1%e5%8f%af%e7%82%ba%e5%81%a5%e4%bf%9d%e8%b2%a1%e5%8b%99%e7%bc%ba%e5%8f%a3%e7%95%a5%e7%9b%a1%e6%a3%89%e8%96%84%e4%b9%8b","status":"publish","type":"post","link":"https:\/\/case.ntu.edu.tw\/blog\/?p=33375","title":{"rendered":"\u300c\u751f\u7269\u76f8\u4f3c\u85e5\u300d\u6216\u8a31\u53ef\u70ba\u5065\u4fdd\u8ca1\u52d9\u7f3a\u53e3\u7565\u76e1\u68c9\u8584\u4e4b\u529b"},"content":{"rendered":"

\u25a0\u4f60\u77e5\u9053\u53f0\u7063\u6700\u4ee4\u4eba\u611f\u5230\u9a55\u50b2\u7684\u5168\u6c11\u5065\u4fdd\uff0c\u5176\u9f90\u5927\u7684\u8ca1\u52d9\u7f3a\u53e3\u53ef\u80fd\u5373\u5c07\u5c0e\u81f4\u7834\u7522\uff1f\u96d6\u7136\u4e2d\u83ef\u6c11\u570b\u842c\u842c\u7a05\u5df2\u4e0d\u662f\u65b0\u9bae\u4e8b\uff0c\u4e0d\u904e\u9664\u4e86\u7e7c\u7e8c\u5c0d\u5c0f\u8001\u767e\u59d3\u8abf\u6f32\u5065\u4fdd\u8cbb\u7684\u958b\u6e90\u4e4b\u6cd5\uff0c\u662f\u5426\u9084\u6709\u5176\u4ed6\u7684\u7bc0\u6d41\u4e4b\u9053\uff1f\u6216\u8a31\u300c\u751f\u7269\u76f8\u4f3c\u85e5\u300d\u80fd\u5e6b\u4e0a\u5065\u4fdd\u4e00\u81c2\u4e4b\u529b\u3002<\/strong><\/span><\/p>\n

\"\"\u64b0\u6587\uff5c<\/strong>\u694a\u671d\u5091<\/strong><\/p>\n

\u25cf<\/b>\u5168\u6c11\u5065\u4fdd\u8ca1\u52d9\u7f3a\u53e3\u5feb\u6490\u4e0d\u904e\u5bd2\u51ac<\/strong><\/span><\/p>\n

2019 \u5e74\u5373\u5c07\u5230\u4f86\uff0c\u5c46\u6642\u5065\u4fdd\u7e3d\u984d\u5c07\u9996\u6b21\u7a81\u7834 7000 \u5104\u5927\u95dc\uff0c\u800c\u5728 2018 \u5e74\u7d2f\u7a4d\u81f3\u7b2c\u4e8c\u5b63\u7684\u5065\u4fdd\u7e3d\u984d\u70ba 6853 \u5104\u5143\uff0c\u4eca\u5e74\u5ea6\u6536\u652f\u4e0d\u5e73\u8861\u9810\u4f30\u9ad8\u9054\u300c\u8ca0\u300d257 \u5104\u5143\uff0c\u66f4\u8b93\u4eba\u64d4\u5fc3\u7684\u662f\u885b\u798f\u90e8\u9810\u4f30 2019 \u5e74\u8ca1\u52d9\u7f3a\u53e3\u53ef\u80fd\u8d85\u904e 500 \u5104\u5143\u3002\u96a8\u8457\u672a\u4f86\u4eba\u53e3\u7d50\u69cb\u8001\u5316\u3001\u6162\u6027\u75c5\u65cf\u7fa4\u9010\u6f38\u589e\u52a0\uff0c\u518d\u52a0\u4e0a\u91ab\u85e5\u9818\u57df\u5feb\u901f\u5730\u767c\u5c55\uff0c\u8a31\u591a\u65b0\u7684 (\u66f4\u8cb4\u7684) \u85e5\u7269\u9678\u7e8c\u63a8\u51fa\uff0c\u7642\u6548\u66f4\u597d\u7684\u65b0\u85e5\u7269\u4e5f\u5927\u5e45\u5ef6\u9577\u4e86\u75c5\u60a3\u7684\u58fd\u547d\uff0c\u53ef\u4ee5\u60f3\u898b\u5065\u4fdd\u7684\u8ca0\u64d4\u53ea\u6709\u66f4\u91cd\u6c92\u6709\u6700\u91cd\u3002\u7136\u800c\uff0c\u5065\u4fdd\u7684\u8ca1\u52d9\u60c5\u6cc1\u8907\u96dc\uff0c\u4e0d\u662f\u672c\u6587\u4e09\u8a00\u5169\u8a9e\u5c31\u80fd\u8f15\u6613\u89e3\u6c7a\u7684\u3002\u6b64\u8655\uff0c\u53ea\u662f\u60f3\u8ac7\u8ac7\u672c\u6587\u7684\u4e3b\u89d2\u300c\u751f\u7269\u76f8\u4f3c\u85e5\u300d\uff0c\u662f\u5426\u80fd\u5728\u9019\u5834\u56b4\u5bd2\u96ea\u4e2d\u591a\u5c11\u9001\u9ede\u70ad\uff1f<\/p>\n

\u25cf<\/b>\u4ec0\u9ebc\u662f\u751f\u7269\u76f8\u4f3c\u85e5\uff1f<\/strong><\/span><\/p>\n

\u300c\u751f\u7269\u76f8\u4f3c\u85e5 (biosimilar)\u300d\uff0c\u770b\u5230\u9019\u500b\u540d\u7a31\u4f60\u4e00\u5b9a\u611f\u5230\u5f88\u5947\u602a\uff0c\u4e00\u7a2e\u85e5\u5c31\u662f\u76f8\u540c\u7684\u4e00\u7a2e\u85e5\uff0c\u70ba\u4f55\u9084\u8981\u7528\u300c\u76f8\u4f3c\u300d\u4f86\u5f62\u5bb9\uff1f\u5728\u56de\u7b54\u9019\u500b\u7591\u554f\u524d\uff0c\u6211\u5011\u5f97\u5148\u7406\u89e3\u5728\u50b3\u7d71\u5316\u5b78\u85e5\u70ba\u4e3b\u7684\u6642\u4ee3\uff0c\u7576\u539f\u5ee0\u5316\u5b78\u85e5\u7684\u5c08\u5229\u904e\u671f\u5f8c\uff0c\u4e0d\u540c\u5bb6\u85e5\u5ee0\u53ef\u4ee5\u4eff\u88fd\u76f8\u540c\u7684\u5316\u5b78\u5206\u5b50\u7d50\u69cb\uff0c\u7a31\u4e4b\u70ba\u300c\u5b78\u540d\u85e5 (generic drug)\u300d\uff0c\u7531\u65bc\u5316\u5b78\u5206\u5b50\u7d50\u69cb\u53ef\u4ee5\u9054\u5230\u5b8c\u5168\u4e00\u81f4 (identical)\uff0c\u6240\u4ee5\u6c92\u6709\u662f\u5426\u300c\u76f8\u4f3c\u300d\u7684\u554f\u984c\u3002\u5b78\u540d\u85e5\u5728\u552e\u50f9\u4e0a\u4e00\u5b9a\u6bd4\u539f\u5ee0\u85e5\u66f4\u4fbf\u5b9c\uff0c\u56e0\u70ba\u53ea\u9700\u6a21\u4eff\u800c\u5c11\u4e86\u958b\u767c\u8cbb\u7528\uff0c\u539f\u5ee0\u85e5\u4e5f\u4e0d\u80fd\u518d\u7368\u5360\u5e02\u5834\uff0c\u9019\u5c31\u50cf\u662f\u539f\u672c\u53ea\u6709\u4e00\u5bb6\u4fbf\u7576\u5e97\u7684\u8857\u4e0a\uff0c\u7a81\u7136\u958b\u4e86\u5341\u5bb6\u4fbf\u7576\u5e97\uff0c\u6d88\u8cbb\u8005\u5c31\u80fd\u7528\u66f4\u512a\u60e0\u7684\u50f9\u683c\u8cb7\u5230\u4fbf\u7576\u3002\u63a5\u4e0b\u4f86\u6211\u5011\u4ee5\u6b64\u985e\u63a8\uff0c\u7576\u539f\u5ee0\u751f\u7269\u85e5\u7684\u5c08\u5229\u904e\u671f\uff0c\u4e0d\u540c\u5bb6\u85e5\u5ee0\u53ef\u4ee5\u958b\u59cb\u4eff\u88fd\u9019\u9805\u751f\u7269\u85e5\uff0c\u6b64\u6642\u5c31\u7a31\u4e4b\u70ba\u300c\u751f\u7269\u76f8\u4f3c\u85e5\u300d\u3002\u540c\u7406\u53ef\u8b49\uff0c\u751f\u7269\u76f8\u4f3c\u85e5\u7684\u552e\u50f9\u4e00\u5b9a\u76f8\u5c0d\u6bd4\u539f\u5ee0\u751f\u7269\u85e5\u4fbf\u5b9c\u3002<\/p>\n

\u25cf<\/b>\u70ba\u4ec0\u9ebc\u4eff\u88fd\u7684\u751f\u7269\u85e5\u53ea\u80fd\u9054\u5230\u300c\u76f8\u4f3c\u300d\uff1f<\/strong><\/span><\/p>\n

\u81ea\u7136\u754c\u4e2d\u300c\u96ea\u82b1\u300d\u7684\u7279\u6027\u5f88\u9069\u5408\u7528\u4f86\u5f62\u5bb9\u751f\u7269\u76f8\u4f3c\u85e5\u7684\u60c5\u6cc1\uff0c\u6211\u5011\u66c9\u5f97\u96ea\u82b1\u4e4d\u770b\u8d77\u4f86\u90fd\u5341\u5206\u4e00\u81f4\uff0c\u4f46\u5728\u5fae\u89c0\u4e0b\uff0c\u57fa\u672c\u4e0a\u6c92\u6709\u5169\u7247\u5b8c\u5168\u76f8\u540c\u7684\u96ea\u82b1\u7d50\u69cb\u3002\u751f\u7269\u85e5\u662f\u4e00\u7a2e\u900f\u904e\u57fa\u56e0\u8868\u73fe\u6280\u8853\u88fd\u9020\u7684\u7522\u54c1\uff0c\u5177\u6709\u56db\u7d1a\u7d50\u69cb\u7279\u6027\uff0c\u5c31\u7b97\u662f\u7b2c\u4e00\u7d1a\u80fa\u57fa\u9178\u5e8f\u5217\u5b8c\u5168\u4e00\u81f4\uff0c\u5176\u4ed6\u4e8c\u7d1a\u4ee5\u4e0a\u7d50\u69cb\u672a\u5fc5\u5b8c\u5168\u76f8\u540c\uff0c\u6240\u4ee5\u751f\u7269\u76f8\u4f3c\u85e5\u5148\u5929\u5373\u5b58\u5728\u5fae\u5c0f\u7570\u8cea\u6027 (microheterogeneity)\uff0c\u88fd\u9020\u904e\u7a0b\u4e5f\u6703\u5f71\u97ff\u85e5\u7269\u7d50\u69cb\u7684\u91cd\u8981\u6539\u8b8a\uff0c\u6b64\u5916\u751f\u7269\u85e5\u7684\u5206\u5b50\u5927\u5c0f\u6bd4\u8d77\u50b3\u7d71\u5316\u5b78\u85e5\uff0c\u5927\u4e86\u81f3\u5c11\u4e00\u767e\u5230\u4e0a\u5343\u500d\uff0c\u5206\u5b50\u7d50\u69cb\u7684\u8907\u96dc\u5ea6\u660e\u986f\u4e0d\u662f\u540c\u4e00\u7d1a\u5225\u3002\u518d\u52a0\u4e0a\u88fd\u9020\u6280\u8853\u4e0a\u7684\u8907\u96dc\u6027\uff0c\u4f7f\u5f97\u751f\u7269\u76f8\u4f3c\u85e5\u662f\u5426\u80fd\u76f4\u63a5\u53d6\u4ee3\u539f\u5ee0\u751f\u7269\u85e5\u6210\u70ba\u6700\u53d7\u722d\u8b70\u7684\u554f\u984c\u3002\u4e0d\u904e\uff0c\u6b50\u7f8e\u7684\u85e5\u54c1\u76e3\u7ba1\u6a5f\u69cb\u90fd\u5df2\u5f9e\u6cd5\u898f\u5c64\u9762\u56b4\u683c\u8981\u6c42\u751f\u7269\u76f8\u4f3c\u85e5\uff0c\u5fc5\u9808\u78ba\u8a8d\u9019\u7a2e\u5fae\u5c0f\u5dee\u7570\u5c0d\u65bc\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u3001\u514d\u75ab\u8a98\u5c0e\u6027\u8cea\u7b49\u9762\u5411\uff0c\u4e0d\u5b58\u5728\u81e8\u5e8a\u4e0a\u7684\u5dee\u7570\u3002\u5be6\u969b\u4e0a\uff0c\u6b50\u6d32\u53ca\u7f8e\u570b\u4e5f\u5df2\u6838\u51c6\u4e0d\u5c11\u751f\u7269\u76f8\u4f3c\u85e5\u4e0a\u5e02\uff0c\u53f0\u7063\u4e5f\u6709\u5e7e\u7a2e\u751f\u7269\u76f8\u4f3c\u85e5\u5df2\u6838\u51c6\u4e0a\u5e02\u3002\u6839\u64da\u6b50\u7f8e\u5c0d\u751f\u7269\u76f8\u4f3c\u85e5\u4e0a\u5e02\u5f8c\u7684\u5b89\u5168\u6027\u7814\u7a76\u986f\u793a\uff0c95% \u4ee5\u4e0a\u7684\u7522\u54c1\u70ba\u53ef\u8ffd\u6eaf\u4e26\u53ef\u8b58\u5225\uff0c\u4e26\u4e14\u6c92\u6709\u51fa\u73fe\u975e\u9810\u671f\u7684\u5b89\u5168\u6027\u8a0a\u865f\uff0c\u9019\u610f\u5473\u8457\u76ee\u524d\u5df2\u4e0a\u5e02\u7684\u751f\u7269\u76f8\u4f3c\u85e5\u5177\u6709\u53ef\u63a5\u53d7\u7684\u5b89\u5168\u6027\u3002<\/p>\n

\u25cf<\/b>\u751f\u7269\u76f8\u4f3c\u85e5\u80fd\u7701\u4e0b\u591a\u5c11\u9322\uff1f<\/strong><\/span><\/p>\n

\u96d6\u7136\u8ac7\u9322\u50b7\u611f\u60c5\uff0c\u4f46\u662f\u5065\u4fdd\u5df2\u5728\u7834\u7522\u908a\u7de3\uff0c\u9322\u82b1\u53bb\u54ea\u88e1\uff1f\u8a72\u600e\u9ebc\u6709\u6548\u76ca\u7684\u82b1\uff1f\u90fd\u662f\u8a72\u9762\u5c0d\u7684\u554f\u984c\u3002\u6211\u5011\u4ee5\u5c08\u5229\u65bc 2015 \u5e74\u5230\u671f\u3001\u6cbb\u7642\u6162\u6027\u6dcb\u5df4\u7403\u6027\u767d\u8840\u75c5\u7684\u77e5\u540d\u85e5\u7269 rituximab \u70ba\u4f8b\uff0c\u5176\u539f\u5ee0\u85e5\u5728 2017 \u5e74\u5168\u7403\u7684\u92b7\u552e\u984d\u7d04 81 \u5104\u7f8e\u5143\u3002\u901a\u5e38\u751f\u7269\u76f8\u4f3c\u85e5\u50f9\u683c\u5927\u7d04\u662f\u539f\u50f9\u7684 7 \u6298\uff0c\u6975\u7aef\u5047\u8a2d\u5168\u7403\u90fd\u6539\u7528 rituximab \u7684\u751f\u7269\u76f8\u4f3c\u85e5\uff0c\u4e00\u5e74\u53ef\u4ee5\u7701\u4e0b\u7d04 24 \u5104\u7f8e\u5143\u3002\u4ee5\u4e0a\u9084\u50c5\u662f\u55ae\u7528\u4e00\u7a2e\u751f\u7269\u76f8\u4f3c\u85e5\u4f86\u8a08\u7b97\u7684\u7d50\u679c\uff0c\u5c31\u80fd\u5920\u7bc0\u7701\u9019\u9ebc\u591a\u8cbb\u7528\u3002\u6240\u8b02\u8b58\u6642\u52d9\u8005\u70ba\u4fca\u5091\uff0c\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u81ea 2017 \u5e74\u8d77\uff0c\u958b\u59cb\u52a0\u901f\u751f\u7269\u76f8\u4f3c\u85e5\u7684\u5be9\u6838\u8207\u6279\u51c6\uff1b\u6b50\u6d32\u66f4\u65e9\u5728 2006 \u5e74\u958b\u59cb\u81f3\u4eca\u5df2\u6279\u51c6 44 \u9805\u751f\u7269\u76f8\u4f3c\u85e5\u3002\u8d81\u8457\u4e0d\u5c11\u6602\u8cb4\u7684\u539f\u5ee0\u751f\u7269\u85e5\u5c08\u5229\u5230\u671f\uff0c\u53f0\u7063\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\u61c9\u8a72\u4e5f\u5f97\u52a0\u7dca\u8173\u6b65\u63a8\u5ee3\u751f\u7269\u76f8\u4f3c\u85e5\uff0c\u6216\u8a31\u80fd\u70ba\u5065\u4fdd\u8ca1\u52d9\u722d\u5f97\u4e00\u7dda\u751f\u6a5f\u3002<\/p>\n

 <\/p>\n

\u53c3\u8003\u8cc7\u6599\uff1a<\/strong><\/p>\n

    \n
  1. Abby Huang\uff0c\u95dc\u9375\u8a55\u8ad6\uff0c09.26\uff0c\u670d\u52d9\u300c\u7121\u9650\u4f9b\u7d66\u300d\uff0c\u5168\u6c11\u5065\u4fdd\u4eca\u5e74\u8667\u640d\u76f4\u903c257\u5104\u5143\u30012021\u5e74\u6050\u558a\u6f32<\/a><\/li>\n
  2. G\u00e1mez-Belmonte R, et al. Pharmacol Res. 2018;133:251-264. Biosimilars: Concepts and controversies.<\/a><\/li>\n
  3. Vez\u00e9r B, et al. Curr Med Res Opin. 2016;32:829-34. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents.<\/a><\/li>\n
  4. \u738b\u7fa4\u529b\uff0c\u79d1\u6280\u767c\u5c55\u89c0\u6e2c\u5e73\u53f0\uff0c05.05\uff0c\u6b50\u76df\u751f\u7269\u76f8\u4f3c\u6027\u85e5\u54c1\u6307\u5357-\u5c08\u696d\u7248<\/a><\/li>\n
  5. Vermeer NS, et al. Drug Saf. 2013;36:617-25. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.<\/a><\/li>\n
  6. GENEONLINE\uff0c05.22\uff0c\u5341\u5927\u5168\u7403\u66a2\u92b7\u85e5\u7269\uff1a Humira \u69ae\u767b\u51a0\u8ecd\u5bf6\u5ea7<\/a><\/li>\n
  7. \u6c5f\u6b23\u76c8\uff0c09.19\uff0c\u751f\u7269\u76f8\u4f3c\u85e5\u722d\u596a\u6230\u80cc\u5f8c\u7684\u89d2\u529b\u904a\u6232<\/a><\/li>\n<\/ol>\n

     <\/p>\n

    \"\u52a0\u5165\u597d\u53cb\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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