{"id":57060,"date":"2026-04-08T00:00:56","date_gmt":"2026-04-07T15:00:56","guid":{"rendered":"https:\/\/www.sanctionlab.com\/?p=57060"},"modified":"2026-04-08T15:12:04","modified_gmt":"2026-04-08T06:12:04","slug":"%e7%be%8e-fda-%ec%8a%b9%ec%9d%b8-%ec%97%86%ec%9d%b4-%eb%b3%b5%ec%a0%9c%ec%95%bd-%eb%af%b8%eb%a6%ac-%eb%93%a4%ec%97%ac-%ec%99%80%eb%8f%84-%eb%90%98%eb%82%98itc-%ec%a0%9c%ec%86%8c%ec%97%90","status":"publish","type":"post","link":"https:\/\/www.sanctionlab.com\/?p=57060","title":{"rendered":"\u7f8e FDA \uc2b9\uc778 \uc5c6\uc774 \ubcf5\uc81c\uc57d \ubbf8\ub9ac \ub4e4\uc5ec \uc640\ub3c4 \ub418\ub098?\u2026ITC \uc81c\uc18c\uc5d0 \uc5c5\uacc4 \ube44\uc0c1"},"content":{"rendered":"<p>\uc81c\ub128\ud14d(Genentech)\uc774 2\uc6d4 27\uc77c(\ud604\uc9c0\uc2dc\uac01) \ubbf8\uad6d \uad6d\uc81c\ubb34\uc5ed\uc704\uc6d0\ud68c(ITC)\uc5d0 \ubc14\uc774\uc624\ucf58(Biocon)\uc744 \uc0c1\ub300\ub85c <a href=\"https:\/\/biologicshq.com\/wp-content\/uploads\/2026\/03\/ITC-337-3890-20260227-Complaint.pdf\">\uc81c\uc18c<\/a>\ud568. \uc81c\ub128\ud14d\uc740 \ud56d\uc554\uc81c \ud37c\uc81c\ud0c0(Perjeta\u00ae, \ud37c\ud22c\uc8fc\ub9d9)\ub97c \uac1c\ubc1c\ud55c \ubbf8\uad6d \uc81c\uc57d\uc0ac\uc774\uace0, \ubc14\uc774\uc624\ucf58\uc740 \ud574\ub2f9 \uc57d\uacfc \uc720\uc0ac\ud55c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\ub97c \uac1c\ubc1c \uc911\uc778 \uc778\ub3c4 \uae30\uc5c5\uc784. \ubb38\uc81c\ub294 \ubc14\uc774\uc624\ucf58\uc774 \uc544\uc9c1 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA) \uc2b9\uc778\uc744 \ubc1b\uc9c0 \uc54a\uc740 \uc0c1\ud0dc\uc5d0\uc11c \ud574\ub2f9 \uc81c\ud488\uc744 \ubbf8\uad6d\uc73c\ub85c \ub300\ub7c9 \uc218\uc785\ud588\ub2e4\ub294 \uc810\uc784. \uc81c\ub128\ud14d\uc740 \uc774\ub97c \ub2e8\uc21c \uc2dc\ud5d8 \ubaa9\uc801\uc774 \uc544\ub2c8\ub77c \ud5a5\ud6c4 \ud310\ub9e4\ub97c \uc704\ud55c \uc0ac\uc804 \ubb3c\ub7c9 \ud655\ubcf4\ub85c \ubcf4\uace0 \uc788\uace0, \uc774\ub294 \ud5c8\uac00 \uc804 \ub2e8\uacc4\uc5d0\uc11c \ud5c8\uc6a9\ub418\ub294 \ubc94\uc704\ub97c \ub118\uc5b4\uc120 \ud589\uc704\ub77c\uace0 \uc8fc\uc7a5\ud568. \uc774\uc5d0 \ub530\ub77c \ud574\ub2f9 \uc81c\ud488\uc758 \uc218\uc785\uc744 \ub9c9\uace0 \ud310\ub9e4\ub97c \uc911\ub2e8\uc2dc\ud0a4\uae30 \uc704\ud574 ITC\uc5d0 \uc81c\uc18c\ud568.<\/p>\n<h4>\ud5c8\uac00 \uc804 \ub300\ub7c9 \uc218\uc785\uacfc &#8216;\uc138\uc774\ud504 \ud558\ubc84 \ubc94\uc704&#8217; \ub17c\uc7c1<\/h4>\n<p>\uc0ac\uac74\uc758 \uc7c1\uc810\uc740 \ud06c\uac8c \ub450 \uac00\uc9c0\uc784. \uccab \ubc88\uc9f8\ub294 \ubc14\uc774\uc624\ucf58\uc774 \uc544\uc9c1 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA) \uc2b9\uc778\uc744 \ubc1b\uc9c0 \uc54a\uc740 \uc0c1\ud0dc\uc5d0\uc11c \uc81c\ud488\uc744 \ubbf8\uad6d\uc73c\ub85c \ub4e4\uc5ec\uc654\ub2e4\ub294 \uc810\uc784. \uc791\ub144 10\uc6d4 \uae30\uc900\uc73c\ub85c 1\ub9cc7800\uac1c \uc774\uc0c1\uc758 \ubb3c\ub7c9\uc774 &#8220;BMAB 1500&#8243;\uc774\ub77c\ub294 \uc774\ub984\uc73c\ub85c \uc218\uc785\ub41c \uae30\ub85d\uc774 \ud655\uc778\ub428. \uc81c\ub128\ud14d\uc740 \uc774\ub97c \ub2e8\uc21c \uc2dc\ud5d8 \ubaa9\uc801\uc774 \uc544\ub2c8\ub77c \ud5a5\ud6c4 \ud310\ub9e4\ub97c \uc704\ud55c &#8216;\uc0ac\uc804 \ubb3c\ub7c9 \ud655\ubcf4(\uc2a4\ud1a1\ud30c\uc77c\ub9c1)&#8217;\ub85c \ubcf4\uace0 \uc788\uc74c.<\/p>\n<p>\ub450 \ubc88\uc9f8 \uc7c1\uc810\uc740 &#8216;\uc138\uc774\ud504 \ud558\ubc84(safe harbor)&#8217; \uc801\uc6a9 \uc5ec\ubd80\uc784. \uc77c\ubc18\uc801\uc73c\ub85c \uc81c\uc57d\ud68c\uc0ac\ub294 \ud5c8\uac00 \uc900\ube44\ub97c \uc704\ud574 \uc77c\uc815 \ubc94\uc704\uc758 \uc0dd\uc0b0\uacfc \uc2dc\ud5d8\uc744 \ud5c8\uc6a9\ubc1b\uc74c. \ud558\uc9c0\ub9cc \uc81c\ub128\ud14d\uc740 \uc774\ubc88 \uc218\uc785\uc774 \uadf8 \ubc94\uc704\ub97c \ub118\ub294 \uc0c1\uc5c5\uc801 \ud589\uc704\ub77c\uace0 \uc8fc\uc7a5\ud568. \uc989, \uc5f0\uad6c \ubaa9\uc801\uc774 \uc544\ub2c8\ub77c \uc2e4\uc81c \ud310\ub9e4\ub97c \uc5fc\ub450\uc5d0 \ub454 \uc900\ube44 \ub2e8\uacc4\ub77c\ub294 \uc785\uc7a5\uc784.<\/p>\n<h4>\uc870\uc131\ubb3c \ubc0f \uc81c\uc870\uacf5\uc815 \ud2b9\ud5c8 \uce68\ud574 \uc8fc\uc7a5<\/h4>\n<p data-start=\"48\" data-end=\"140\">\ud2b9\ud5c8 \uce68\ud574 \ubb38\uc81c\ub3c4 \ud568\uaed8 \uc81c\uae30\ub428. \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\ub77c\uace0 \ud574\uc11c \ud2b9\ud5c8 \ubb38\uc81c\uac00 \uc5c6\ub294 \uac83\uc740 \uc544\ub2d8. \ubc14\uc774\uc624\uc758\uc57d\ud488\uc740 \uc57d \uc790\uccb4\ubfd0 \uc544\ub2c8\ub77c \ub9cc\ub4dc\ub294 \ubc29\ubc95\uae4c\uc9c0 \uc5ec\ub7ec \ud2b9\ud5c8\ub85c \ubcf4\ud638\ub418\uae30 \ub54c\ubb38\uc784. \uc774\ubc88 \uc0ac\uac74\uc5d0\uc11c \uc81c\ub128\ud14d\uc740 \ubc14\uc774\uc624\ucf58 \uc81c\ud488\uc774 \uc57d\uc758 \uad6c\uc131\ubfd0 \uc544\ub2c8\ub77c \uc81c\uc870 \uacfc\uc815\uc5d0\uc11c\ub3c4 \uc790\uc0ac\uc758 \ud2b9\ud5c8\ub97c \uce68\ud574\ud588\ub2e4\uace0 \uc8fc\uc7a5\ud568. \uc989, \ub2e8\uc21c\ud788 \ube44\uc2b7\ud55c \uc57d\uc744 \ub9cc\ub4e0 \uac83\uc744 \ub118\uc5b4, \ud574\ub2f9 \uc57d\uc744 \ub9cc\ub4dc\ub294 \uacfc\uc815\uc5d0\uc11c\ub3c4 \ud2b9\ud5c8 \uae30\uc220\uc774 \uc0ac\uc6a9\ub410\ub2e4\ub294 \uc785\uc7a5\uc784. \uc989, &#8220;\ube44\uc2b7\ud55c \uc57d\uc744 \ub9cc\ub4dc\ub294 \uac83 \uc790\uccb4\ub294 \uac00\ub2a5\ud558\uc9c0\ub9cc, \uadf8 \uacfc\uc815\uc5d0\uc11c \uae30\uc874 \ud68c\uc0ac\uc758 \uae30\uc220\uae4c\uc9c0 \uc0ac\uc6a9\ud558\uba74 \ubb38\uc81c\uac00 \ub420 \uc218 \uc788\ub2e4&#8221;\ub294 \uad6c\uc870\uc784.<\/p>\n<h4>\uacf5\uc775\uc131 \ubc0f \ubbf8\uad6d \uc0b0\uc5c5 \ubcf4\ud638 \uce21\uba74 \uc8fc\uc7a5<\/h4>\n<p>ITC\ub294 \uc218\uc785\uae08\uc9c0 \uc870\uce58\ub97c \ub0b4\ub9ac\uae30 \uc804, \ud574\ub2f9 \uc870\uce58\ub85c \uc778\ud574 \ud658\uc790, \uc18c\ube44\uc790, \uc2dc\uc7a5 \ub4f1\uc5d0 \ubd80\uc815\uc801\uc778 \uc601\ud5a5\uc774 \ubc1c\uc0dd\ud558\uc9c0 \uc54a\ub294\uc9c0(\uacf5\uc775\uc131)\ub3c4 \ud568\uaed8 \uace0\ub824\ud558\ub294\ub370, \uc81c\ub128\ud14d\uc740 \ud574\ub2f9 \uc81c\ud488\uc774 \uc544\uc9c1 FDA \uc2b9\uc778\uc744 \ubc1b\uc9c0 \uc54a\uc740 \uc0c1\ud0dc\uc774\uae30 \ub54c\ubb38\uc5d0 \uc218\uc785\uc744 \ub9c9\ub354\ub77c\ub3c4 \ud658\uc790 \uce58\ub8cc\uc5d0 \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc740 \uc5c6\ub2e4\ub294 \uc785\uc7a5\uc784. \ub2e4\uc2dc \ub9d0\ud574, \uc774\ubbf8 \uc0ac\uc6a9 \uc911\uc778 \uce58\ub8cc\uc81c\uac00 \uc2dc\uc7a5\uc5d0\uc11c \uc0ac\ub77c\uc9c0\ub294 \uac83\uc774 \uc544\ub2c8\ubbc0\ub85c \uacf5\uc775\uc5d0\ub3c4 \ubc18\ud558\uc9c0 \uc54a\ub294\ub2e4\ub294 \ub17c\ub9ac\uc784.<\/p>\n<p>\ub610\ud55c \uc218\uc785\uae08\uc9c0 \uc870\uce58\uac00 \ubbf8\uad6d \ub0b4 \uc0b0\uc5c5\uacfc \uacbd\uc81c\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5\ub3c4 \ud568\uaed8 \uace0\ub824\ud558\ub294\ub370, \uc81c\ub128\ud14d\uc740 \ud37c\uc81c\ud0c0\ub97c \ubbf8\uad6d \ub0b4\uc5d0\uc11c \uc0dd\uc0b0\ud558\uace0 \uc788\ub2e4\ub294 \uc810\uc744 \uac15\uc870\ud568. \uc774\uc5d0 \ub530\ub77c \uc218\uc785 \uc81c\ud55c \uc870\uce58\ub294 \ubbf8\uad6d \uc0b0\uc5c5 \ubcf4\ud638\uc640 \uacbd\uc7c1\ub825 \uc720\uc9c0 \uce21\uba74\uc5d0\uc11c\ub3c4 \uae0d\uc815\uc801\uc774\ub77c\ub294 \uc8fc\uc7a5\uc784. \ud574\uc678 \uc0dd\uc0b0 \uc81c\ud488 \uc720\uc785\uc744 \uc81c\ud55c\ud568\uc73c\ub85c\uc368 \uc790\uad6d \uc81c\uc870 \uae30\ubc18\uc744 \ubcf4\ud638\ud560 \uc218 \uc788\ub2e4\ub294 \ub17c\ub9ac\uc784.<\/p>\n<h4>\uc720\uc0ac \ubd84\uc7c1 \ud750\ub984\uacfc \uc2dc\uc0ac\uc810<\/h4>\n<p>\ud574\ub2f9 \uc0ac\uc548\uc740 \ucd5c\uadfc \uc788\uc5c8\ub358 \uc720\uc0ac \ubd84\uc7c1\uacfc\ub3c4 \uc5f0\uacb0\ub428. \uc81c\ub128\ud14d\uc740 2025\ub144 \uc0c1\ud558\uc774 \ud5e8\ub9ac\uc6b0\uc2a4(Shanghai Henlius)\uc640 \uc624\uac00\ub17c(Organon)\uc744 \uc0c1\ub300\ub85c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uad00\ub828 \uc18c\uc1a1\uc744 \uc9c4\ud589\ud588\uace0, \ud574\ub2f9 \uc81c\ud488\uc740 FDA \uc2b9\uc778\uc744 \ubc1b\uc740 \uc774\ud6c4 2026\ub144 \ucd08 \ud569\uc758\ub85c \ub9c8\ubb34\ub9ac\ub41c \ubc14 \uc788\uc74c. \uc989, \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\ub97c \ub458\ub7ec\uc2fc \uacbd\uc7c1\uacfc \ubd84\uc7c1\uc774 \uacc4\uc18d \uc774\uc5b4\uc9c0\uace0 \uc788\ub294 \ud750\ub984\uc784.<\/p>\n<p>\ud2b9\ud788, \uc774\ubc88 \uc0ac\uac74\uc740 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uae30\uc5c5\ub4e4\uc774 \ud5c8\uac00 \uc774\uc804 \ub2e8\uacc4\uc5d0\uc11c \uc5b4\ub290 \uc218\uc900\uae4c\uc9c0 \uc0dd\uc0b0\u00b7\uc218\uc785\uc744 \ud560 \uc218 \uc788\ub294\uc9c0\uc5d0 \ub300\ud55c \uacbd\uacc4\ub97c \ubcf4\uc5ec\uc90c. \ub2e8\uc21c\ud55c \uc2dc\ud5d8 \ubaa9\uc801\uc744 \ub118\uc5b4\uc11c\ub294 \ubb3c\ub7c9 \ud655\ubcf4\ub294 \ubc95\uc801 \ubd84\uc7c1\uc73c\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc74c\uc744 \uc2dc\uc0ac\ud568. \ub610\ud55c \uc758\uc57d\ud488 \ubd84\uc57c\uc5d0\uc11c\ub294 \uc81c\ud488 \uc790\uccb4\ubfd0 \uc544\ub2c8\ub77c \uc81c\uc870 \uacf5\uc815\uae4c\uc9c0 \ud3ec\ud568\ud55c \ud2b9\ud5c8 \uad00\ub9ac\uac00 \uc911\uc694\ud558\ub2e4\ub294 \uc810\uc774 \ub4dc\ub7ec\ub0a8. \ub2e8\uc21c\ud788 \uc131\ubd84\uc744 \uc720\uc0ac\ud558\uac8c \ub9cc\ub4dc\ub294 \uac83\ub9cc\uc73c\ub85c\ub294 \ucda9\ubd84\ud558\uc9c0 \uc54a\uace0, \uc0dd\uc0b0 \ubc29\uc2dd\uae4c\uc9c0 \ud2b9\ud5c8\ub97c \ud68c\ud53c\ud574\uc57c \ud55c\ub2e4\ub294 \uc758\ubbf8\uc784. \uacb0\uacfc\uc801\uc73c\ub85c &#8220;\ud5c8\uac00 \uc804 \uc900\ube44 \ub2e8\uacc4\uc640 \uc0c1\uc5c5\uc801 \ud589\uc704\uc758 \uacbd\uacc4&#8221;\uc640 &#8220;\uc81c\ud488+\uacf5\uc815 \ud1b5\ud569 \ud2b9\ud5c8 \uc804\ub7b5&#8221;\uc758 \uc911\uc694\uc131\uc744 \ubcf4\uc5ec\uc90c. \ud5a5\ud6c4 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uae30\uc5c5\ub4e4\uc758 \uac1c\ubc1c \ubc0f \uc2dc\uc7a5 \uc9c4\uc785 \uc804\ub7b5\uc5d0\ub3c4 \uc601\ud5a5\uc744 \uc904 \uc218 \uc788\ub294 \uc0ac\uc548\uc784.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc81c\ub128\ud14d(Genentech)\uc774 2\uc6d4 27\uc77c(\ud604\uc9c0\uc2dc\uac01) \ubbf8\uad6d \uad6d\uc81c\ubb34\uc5ed\uc704\uc6d0\ud68c(ITC)\uc5d0 \ubc14\uc774\uc624\ucf58(Biocon)\uc744 \uc0c1\ub300\ub85c \uc81c\uc18c\ud568. \uc81c\ub128\ud14d\uc740 \ud56d\uc554\uc81c \ud37c\uc81c\ud0c0(Perjeta\u00ae, \ud37c\ud22c\uc8fc\ub9d9)\ub97c \uac1c\ubc1c\ud55c \ubbf8\uad6d \uc81c\uc57d\uc0ac\uc774\uace0, \ubc14\uc774\uc624\ucf58\uc740 \ud574\ub2f9 \uc57d\uacfc \uc720\uc0ac\ud55c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\ub97c \uac1c\ubc1c \uc911\uc778 \uc778\ub3c4 \uae30\uc5c5\uc784. \ubb38\uc81c\ub294 \ubc14\uc774\uc624\ucf58\uc774 \uc544\uc9c1 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA) \uc2b9\uc778\uc744 \ubc1b\uc9c0 \uc54a\uc740 \uc0c1\ud0dc\uc5d0\uc11c \ud574\ub2f9 \uc81c\ud488\uc744 \ubbf8\uad6d\uc73c\ub85c \ub300\ub7c9 \uc218\uc785\ud588\ub2e4\ub294 \uc810\uc784. \uc81c\ub128\ud14d\uc740 \uc774\ub97c \ub2e8\uc21c \uc2dc\ud5d8 \ubaa9\uc801\uc774 \uc544\ub2c8\ub77c \ud5a5\ud6c4 \ud310\ub9e4\ub97c \uc704\ud55c \uc0ac\uc804 \ubb3c\ub7c9 \ud655\ubcf4\ub85c \ubcf4\uace0 \uc788\uace0, \uc774\ub294 \ud5c8\uac00 [&hellip;]<\/p>\n","protected":false},"author":696,"featured_media":55779,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[612,604],"tags":[10461,58,2288,6894,1925],"class_list":{"0":"post-57060","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-usa","8":"category-export","9":"tag-itc","10":"tag-58","11":"tag-2288","12":"tag-6894","13":"tag-1925"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u7f8e FDA \uc2b9\uc778 \uc5c6\uc774 \ubcf5\uc81c\uc57d \ubbf8\ub9ac \ub4e4\uc5ec \uc640\ub3c4 \ub418\ub098?\u2026ITC \uc81c\uc18c\uc5d0 \uc5c5\uacc4 \ube44\uc0c1 SanctionLab<\/title>\n<meta name=\"description\" content=\"\uc81c\ub128\ud14d(Genentech)\uc774 2\uc6d4 27\uc77c(\ud604\uc9c0\uc2dc\uac04) \ubbf8\uad6d \uad6d\uc81c\ubb34\uc5ed\uc704\uc6d0\ud68c(ITC)\uc5d0 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