バイオシミラーの現状と課題 - masaki.muto.net

1 1 2012 JCI 2017 4 2017 4 2020 2018 4 MBA,MPH 3 7 2000 100 1 10 1 53,103,000 2 51,147,950 3 29,362,500 4 / 29,103,000 5 26,468,400 6 21,889,280 7 19,409,700 8 18,515,690 9 13,860,140 10 12,948,480 11 12,880,000 10 050100150200250201020112012201320142015 2010 2010 10 12 546 12 3,500 1 96 1 2015 5 2014 9 2016 4 5 8 5000 2016 6 24 2015 TOP10 Top10 7 2020 BS 7 2015 3,159 Monthly IHEP 2017/5 1 / C 19,140+54%2 14,357+11%3 9,036+1%4 8,931-10%5 8,675-1%6 7,090-11%7 6,959+9%8 6,807+10%9 II 6,3240%10 6.

2 245+40% 15 FIL5011 15 H27/9/4 VIII A IX B 2 G-CSF CD20 B EGF TNF- HPV . 17 p< , relative risk (95%CI): ( )Slamon DJ et al. N Engl J Med 2001;344:783-92. Copyright (C) 2012 Chugai Pharmaceutical Co.

3 , Ltd. All Rights Reserved. NCNCNCNCNCNC NCNCC 9 , N/C (ELISA, ECL) HPLC HPLC ELISA PDA 2012 1 2 3 0510152025303540 (ICH-Q5E) Source: C Schneider, Ann Rheum Dis March 2013 Vol72 No 3(from MabThera, authorisedon 2 June 1998 for the initial authorisation in oncology,to Benlysta, licensed on 13 July 2011) BMS [ ][ ] 12 28 Schneider CK.

4 Ann Rheum Dis 201372(3)315 8 Schiestl M et al. Nat Biotechnol 2011;29(4):310 2 G0 ICHQ5E . 2015 12 7 ICH International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals for Human Use EU ICH-Q5E 2015 2015 2015 2010 20 33 .Biosimilar. ;2012. 201133 2012-2015 2010-2017 a 2012-20152019 b-1a 2011-2015 2011-20192015 2011-20172021 2013-20192013-2018 2013-20182011-2014 / 2013-20182018-2023 / 20142014-2020 / 20172018- / 20152016-2015 EPO JCR G-CSF / / / / / Meiji Seika EPO /JCR

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6 1. 2. 3.. 1. 2. 3.. 1. 2. 3.. 1. 2. 3.. 1. 2. 3. 4. 5. 6.. 1. 2. 3. 4. 5. 6. 7.. 21 3 4 38 FIL5001 1 Schneider CK et al. Nat Biotechnol. 2012;30 Presented at EMAW orkshop on Biosimilars; London United Kingdom; October 2013. PK/PD PK/PD Ventola CL. P T. 2013;38(5):270-287. 200-300 1000-1800 2-3 7-8 8-10 2-3 500 800-1000 20-50 41 7 2009 ICH( / / ICH-Q5E / ICH EU 11 8 ( A) ( B))

7 A B 5 BS BS BS BS BS 191 2009 166 34000 2010 175 18,7992013 TNF 49 BS BS 100%70~77%70% 10% 52 YooDH, ProdanovicN, JaworskiJ, et al. Efficacy and safety of CT-P13(biosimilarinfliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13and continuing CT-P13in the PLANETRA extension study.

8 Ann Rheum ;Apr29 Park SH, et al. Post-marketing study of biosimilarinfliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev GastroenterolHepatol. 2015;9(suppl1) LJ, et al. Clinical Outcomes Following a Switch from Remicade to the BiosimilarCT-P13in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study. J Apr19. 1 3000 2025 60% 70 3,430 2,140 1,290 80%50%30% 2025 23,819 05,00010,00015,00020,00025,00030,0002009 2010201120122013201420152016201720182019 202020212022202320242025 (BS) (BS) 7 14 A 4 BS BS 57%( 18% 7 )BS ( 18% ) BS 100 2018 3 55 2016 / imshealth (May 2017)

9 The Impact of Biosimilar Competition 34%32%22%39%9%0%20%40%60%80%100% 45%81%6%62%58%0%20%40%60%80%100% 86%78%98%88%62%0%20%40%60%80%100% 14%17%33%24%3%0%20%40%60%80%100% 04%1%4%26%0%20%40%60%80%100% 17 57 ( ) ( ) ( ) ( ) ( ) ( ) 59 1998 60 61 TNF 62 BS 020,00040,00060,00080,000100,000120,0001 24681012 NK 1 10 50kg2 2 8 43 50kg 2 8 65 63 64 40kg ( ) 65 3,507,212 3,298,596 2,761,894 2,746,747 1,839,144 1,740,138 0500,0001,000,0001,500,0002,000,0002,500 ,0003,000,0003,500,0004,000,000N 10mgJ 8mgE 12mgP 12mgM 8mgS 10mg 180 /m g /m gN 10m g9,609P 12m g7,525J 8m g9,037M 8m g5,039E 12m g7,567S 10m g4,768 2014 4 5 600 2220252339151228454239453545432628472633 2028152540286981015018211820%20%40%60%80 %100% (N=121)100 (N=61)100 (N=60) (N=155) (N=33) (N=40) (N=42) (N=40) (N=114)

10 Progress in medicine 2016 2 66 67 DPC 1,000 = 1,000 68 2016 10 13 69 2 70 2017 2017 6 9 2020 32 80