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.

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3 17 p< , relative risk (95%CI): ( )Slamon DJ et al. N Engl J Med 2001;344:783-92. Copyright (C) 2012 Chugai Pharmaceutical Co., Ltd. All Rights Reserved. NCNCNCNCNCNC NCNCC 9 , N/C (ELISA, ECL)

4 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.

5 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 / / / /

6 / Meiji Seika EPO /JCR AnswersNews 2016 7 34 35 0304007 21 3 4 Similar FIL5013 70 10% 36 37

7 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.

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10 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. 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)