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´Ùµé À§ÀÓÀå Àß º¸³»¼ÌÁö¿ä? Àúµµ °¡Á·µé º¸À¯ºÐÀº À§ÀÓÀå º¸³»°í Àú´Â ÁÖÃÑ Âü¼® ¿¹Á¤À̶ø´Ï´Ù. ¿äÁò ÁýÇàºÎ ºÐµé ³Ê¹« ¹Ù»Ú½ÇÅÙµ¥ °¨»çµå¸®°í °í¸¿´Ù´Â ¸»¾¸ µå¸®°í ½Í³×¿ä.

¾îÁ¦ È­ÀÌÀÚ°¡ ¹Ì±¹¿¡¼­ J&JÃø¿¡ ¹Ýµ¶Á¡ ¼Ò¼ÛÀ» Àç±âÇÏ¿´³×¿ä. J&J´Â ¾Æ½Ã´Ù½ÃÇÇ ±×°£ º¸Çè»ç¸¦ ÅëÇØ º´¿øµî ±¸¸ÅÀڵ鿡°Ô Áö±ÞµÇ´Â ¸®º£ÀÌÆ®¸¦ öȸÇÏ°Ú´Ù°í Çϸ鼭 ÀÎÇ÷ºÆ®¶óÀÇ ¹Ì±¹³» ħÅõ¸¦ ¸·¾Æ¿Ô½À´Ï´Ù. È­ÀÌÀÚ´Â J&JÀÇ ÀÌ·¯ÇÑ ÇàÀ§°¡ ¹Ýµ¶Á¡ À§¹ÝÀÌ¸ç ¹ÙÀÌ¿À½Ã¹Ð·¯ÀÇ È®»êÀ» À§ÇØ ¸¸µç Á¤ºÎ Á¤Ã¥ÀÎ BPCIA ¹ý À§¹ÝÀ̶ó°í ÁÖÀåÇÏ°í ÀÖ½À´Ï´Ù.

°£´ÜÈ÷ ¼³¸íµå¸®¸é ¹Ì±¹¿¡¼­´Â º´¿ø¿¡¼­ ¾àÀ» ±¸¸ÅÇϸé ÀÏÁ¤ ¸¶Áø(4.3% reimbursement)À» º¸Çè»ç°¡ º´¿ø¿¡ Ãß°¡·Î Áö±ÞÇÕ´Ï´Ù. ±×·¸±â ¶§¹®¿¡ »ç½Ç ¾à°ªÀÌ ºñ½Ò¼ö·Ï ÀÌ ¸®º£ÀÌÆ®´Â Å« ±Ý¾×ÀÌ µË´Ï´Ù. ·¹¹ÌÄÉÀ̵å¿Í °°Àº °í°¡ÀÇ ¹ÙÀÌ¿ÀÀǾàÇ°ÀÇ ¸®º£ÀÌÆ® ±Ô¸ð´Â ¾öû³­ ±Ý¾×ÀÌ µÉ °ÍÀε¥ ¹Ù·Î ÀÌÁ¡À» °¡Áö°í J&J°¡ º´¿øµî ±¸¸ÅÀÚµéÀ» ¾Ð¹ÚÇØ ¿Ô½À´Ï´Ù. °á±¹ ÀÌ·¡Àú·¡ ȯÀÚ¸¸ °íÅë ¹Þ´Â Á¤Ã¥À̶ó°í »ý°¢ÇÕ´Ï´Ù.

±×·¡¼­ ¹Ì±¹ Á¤ºÎ¿¡¼­ ¾à°¡¸¦ ³·Ãß±â À§ÇØ ¿À¹Ù¸¶ ´ëÅë·É½ÃÀý ¹ÙÀÌ¿À½Ã¹Ð·¯ »ç¿ëÃËÁø¹ýÀ» ¸¸µé¾ú´Âµ¥ ÀÌ°Ô »ý¹°ÇÐÀû Á¦Á¦ ¾à°¡ °æÀï ¹× Çõ½Å¹ý(BPCIA, Biologics Price Competition and Innovation Act) ÀÔ´Ï´Ù. ÀÌ ¹ý¿¡ µû¸£¸é ¹ÙÀÌ¿À½Å¾à Çã°¡ ÈÄ 4³â°£ ¹ÙÀÌ¿À½Ã¹Ð·¯ Çã°¡ ½Åû ±ÝÁö, ¹ÙÀÌ¿À½Å¾à Çã°¡ ÈÄ 4³â°£ ÀڷᵶÁ¡±Ç(Dataexclusivity) ¹× 8³â°£ º°µµÀÇ ÈÄ¼Ó ½ÃÀ嵶Á¡±Ç(Market exclusivity) ºÎ¿©,
ÃÖÃÊ ´ëü °¡´É ¹ÙÀÌ¿À½Ã¹Ð·¯(Interchangeable biosimilar) Çã°¡ ÈÄ ÃÖ¼Ò 1³â°£ µ¶Á¡±Ç ºÎ¿©.. µî ¸¹Àº ±ÔÁ¤°ú °¡À̵尡 ÀÖ½À´Ï´Ù.

ÀÌ ¹ý¿¡ µû¶ó ¹Ì±¹½ÃÀå ÁøÀԽà »êµµ½ºÀÇ À۽ÿÀ¿Í È­ÀÌÀÚÀÇ ÀÎÇ÷ºÆ®¶ó°¡ ¸ðµÎ 180ÀÏÀ» ±â´Ù·È´Ù°¡ ÆǸŰ¡ µÇ¾úÁÒ. ±×·¯¹Ç·Î È­ÀÌÀÚ°¡ ÁÖÀåÇÏ´Â °Íó·³ J&JÀÇ ¸®º£ÀÌÆ®¸¦ öȸÇÏ°Ú´Ù°í º¸Çè»çµé¿¡°Ô °æ°íÇÏ´Â ÇàÀ§³ª ÀÎÇ÷ºÆ®¶ó·Î ÇâÈÄ ¹Ù²ÙÁö ¾Ê°Ú´Ù°í Çؼ­ º£´ÏÇÍÀ» ÁÖ´Â ÇàÀ§´Â ¸í¹éÈ÷ ¹Ýµ¶Á¡ ¹× BPCIA¹ý À§¹ÝÀ̶ó°í Àú ¿ª½Ã »ý°¢ÇÕ´Ï´Ù.


±â»ç¸¦ º¸¸é.. ´õ±Û¶ó½º ·©Å¬·¯ È­ÀÌÀÚ ¼ö¼®ºÎ»çÀåÀº "ÀÇȸ´Â BPCIA¸¦ Á¦Á¤ÇÏ¿© ȯÀÚµéÀÌ º¸´Ù Àú·ÅÇÑ Ä¡·á¸¦ ¹ÞÀ» ¼ö ÀÖµµ·Ï Çß°í »ý¹°ÀǾàÇ°¿¡ ´ëÇÑ ÀǹÌÀÖ´Â °¡°Ý°æÀïÀ» À¯µµÇß½À´Ï´Ù.

J&JÀÇ ÀÏ·ÃÀÇ ÇൿÀº BPCIA¿Í ¹Ì±¹ÀÇ µ¶Á¡±ÝÁö¹ýÀÇ Á¤½Å¿¡ ¹ÝÇÏ´Â °ÍÀÔ´Ï´Ù. ¿ì¸®´Â ȯÀںеéÀÌ Àú·ÅÇÑ ¹ÙÀÌ¿À½Ã¹Ð·¯ Ä¡·á¹ýÀ» ÅëÇØ ÇýÅÃÀ» º¸°í ½±°Ô Ä¡·á¸¦ ¹ÞÀ» ¼ö ÀÖµµ·Ï ÀÌ ¼Ò¼ÛÀ» Á¦±âÇÏ´Â °ÍÀÔ´Ï´Ù." ¶ó°í ¸»ÇÏ°í ÀÖ½À´Ï´Ù.

¡°Congress enacted the BPCIA to improve patient access to more affordable treatment options and to foster meaningful price competition for biologic products,¡± said Douglas Lankler, executive vice president, general counsel, Pfizer Inc. ¡°J&J¡¯s behavior runs counter to the spirit of this law and to U.S. antitrust laws. We are filing this suit to help ensure that patients can benefit from, and have access to, lower cost biosimilar therapies.¡±


À̹ø ¼Ò¼ÛÀº µÎ°¡Áö Å« Àǹ̸¦ °¡Áý´Ï´Ù. ¿ì¼± ¼Ò¼ÛÀÇ °á°ú¿¡ µû¶ó J&J°¡ ±×°£ ÇØ¿Ô´ø ÀÎÇ÷ºÆ®¶ó ÆǸŠ¹æÇØÇàÀ§¸¦ Áß´ÜÇÑ´Ù¸é ¹Ì±¹¿¡¼­ ³»³âºÎÅÍ ÀÎÇ÷ºÆ®¶óÀÇ ÆǸŰ¡ ºñ¾àÀûÀ¸·Î ´Ã¾î³ª°Ô µÉ °ÍÀÔ´Ï´Ù.

»ç½Ç ¾Æ½±Áö¸¸ ¹Ì±¹½ÃÀåÀÇ ±Ô¸ð ´ëºñ ÀÎÇ÷ºÆ®¶ó°¡ ÈξÀ ¸¹ÀÌ ÆÈ·Á¾ß ÇÔ¿¡µµ ºÒ±¸ÇÏ°í ±×·¯Áö ¸øÇÑ ¸éÀÌ ÀÖ¾ú½À´Ï´Ù. ´ÙÇàÈ÷ Æ®·è½Ã¸¶°¡ À¯·´¿¡¼­ ¼±ÀüÇϸ鼭 ÀÌ ºÎºÐÀ» ¸¹ÀÌ Ä¿¹ö ÇØÁÖ°í´Â ÀÖÁö¸¸ ¸¶¶¥È÷ÃÖ÷´Ü ÀǾàÇ°µéÀÇ ÀüÀïÅÍÀÌÀÚ °¡Àå Å« ½ÃÀåÀÎ ¹Ì±¹¿¡¼­ Á¤»óÀûÀ¸·Î ÆǸŰ¡ ÀÌ·ç¾îÁ®¾ß ÇÕ´Ï´Ù.

µÎ¹ø°·Î ÀÌ·¯ÇÑ J&JÀÇ ÇàÀ§°¡ À§¹ýÀ¸·Î ÆÇ°áÀÌ ³­´Ù¸é BPCIA¿¡ µû¶ó ÇâÈÄ ´Ù¸¥ ¹ÙÀÌ¿À½Ã¹Ð·¯µéÀÇ ¹Ì±¹ ÁøÃâ½Ã ¿À¸®Áö³¯ ÀǾàÇ° Á¦Á¶»çµéÀÌ ´õ ÀÌ»ó ¹ÙÀÌ¿À½Ã¹Ð·¯ÀÇ ÆǸŸ¦ ¹æÇØÇÏ´Â ÀÏüÀÇ ÇàÀ§¸¦ ÇÏÁö ¸øÇÏ°Ô µÉ °ÍÀÔ´Ï´Ù.


Ãâó :https://seekingalpha.com/pr/16946312-pfizer-goes-court-allow-competition-biologics-expand-options-patients

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