Table of Content

Chapter 1: EXECUTIVE SUMMARY
Chapter 2: JAPANESE GOVERNMENT AND “CHUIKYO” INITIATIVES TO INCREASE BIOSIMILAR PENETRATION IN JAPAN

  • JBSA- How it will play important role for biosimilar penetration in Japan and overcome BS penetration related issues?


Chapter 3: LESSONS FROM LAUNCHED BIOGENERIC PROGRESS IN JAPAN SINCE 2009

  •  Encouraging uptake for Filgrastim, Insulin glargine, Rituximab and Eternacept BS, while sluggish start for Infliximab demonstrates variable market for each BS – Highly depends on the reimbursement status and front-end presence


Chapter 4: GROWTH HORMONE MARKET (SOMATROPIN) IN JAPAN

  • Despite being the first biosimilar to hit the Japan market, low uptake reported due to the brand loyalty by pediatrician; Long acting growth hormone entry is the upcoming threat


Chapter 5: ANEMIA MARKET IN JAPAN

  • EPO- After an initial struggle, biosimilar of EPO is steadily growing
  • NESP “Biosame” vs. NESP BS uptake - key to watch in 2020


Chapter 6: FILGRASTIM (GRAN) BS

  • G-LASTA uptake squeeze the market for GRAN BSs - Entry of G-lasta biosimilars expected to change the game


Chapter 7: REMICADE (INFLIXIMAB) BS

  • High cost healthcare system and impact of competing products like Simponi in the RA market, key hurdles for the slower biosimilar uptake


Chapter 8: LANTUS (INSULIN GLARGINE) BIOSIMILAR

  • One of the most successful BS launch in Japan –now facing challenges from next generation Lantus (Lantus-XR)


Chapter 9: ENBREL (ETANERCEPT) BIOSIMILAR

  • First Etanercept BS had encouraging early uptake as provides co-pay difference due to low cost vs. other approved Mabs, available in both formulations and strong front end of the commercial partner


Chapter 10: ONCOLOGY BIOSMILARS ERA STARTS WITH RITUXAN (RITUXIMAB) BIOSIMILAR

  • Rituxan biosimilar take off strongly captured major shares from the originator; Gazyva (obinutuzumab) to replace Rituxan is the major threat


Chapter 11: HERCEPTIN (TRASTUZUMAB) BIOSIMILAR

  • Now with approval of all dosing schedules and indications as the originator, three BS players ready to take the market share- Approval of fixed-dose combination of Roche’s Herceptin/Perjeta and new competitors can change the game


Chapter 12: AVASTIN (BEVACIZUMAB) BIOSIMILAR

  • Japan’s best selling drug with sizable market to attract more biosimilar players in the coming future without “Biosame” threat


Chapter 13: FABRAZYME (AGALSIDASE BETA) BIOSIMILAR

  • Niche opportunity captured by Japanese biosimilar rising star, difficulties ahead with the entry of Japan’s first oral treatment for Fabry disease (Galafold)


Chapter 14: FORTEO (TERIPARATIDE) BIOSIMILAR

  • Entry of Evenity –create a headwind despite lower copay & strong front end by Mochida


Chapter 15: NEXT WAVEOF BIOSIMILAR OPPORTUNITIES IN JAPAN

  • Actemra BS a more attractive opportunity in Japan vs. Humira
  • Avastin biosimilar uptake and Opthalmology BS development are key to watch


Chapter 16: BIOSIMILAR/BIOPHARMA CMO OPPORTUNITY

  • Would Japanese conglomerates cater the global market?


Chapter 17: REGULATORY APPROVAL REQUIREMENT FOR COMPLEX MAB BIOSIMILAR IN JAPAN

  • Key take away of JP biosimilar guideline when compared to EU/US requirement
  • JP requirements for the approval of biosimilars


Chapter 18: LICENSING/CONSOLIDATION ACTIVITIES IN BIOSIMILAR SPACE IN JAPAN
Chapter 19: JAPANESE COMPANIES ACTIVE INTO BIOGENERICS SPACE

  • Aska Pharmaceuticals - No major progress on the biobetter
  • Asahi Glass –Entering in Biopharma CDMO Business for Global Market
  • Chugai Pharmaceuticals- Entry to Authorised Biosimilar unlikely - Fighting for originator rights
  • Daiichi Sankyo –Potential to be a front runner in the biosimilar space with Amgen Partnership
  • Fuji Film Kyowa Kirin Biologics (FF-KKB) – Looking beyond domestic opportunities to capture global biosimilar business
  • Fuji Pharma – Alvotech partnership to bolster biosimilar business as its new core in the home ground
  • Gene Techno Science – JP Biopharma rising star - A reliable partner for Developing Biosimilar in Japan by Japanese Front End Companies
  • Itochu Chemical Frontier Corporation – A trading house with new role in biosimilar value chain
  • JCR Pharmaceuticals –A pioneer for biosimilars -now thrive in regenerative medicine & fast tracking NESP biosimilar
  • Kissei – Timely launch of NESP biosimilar – Next to watch! Focus to be a niche player in BS space
  • Kyowa Hakko Kirin – Tapping biosimilar market through “Biosame” launch –Taking advantage of front end leadership for Anemia and Heamatology therapy area
  • Meiji Seika Pharma (MSP) –Trastuzumab biosimilar launch awaited in Japan- Tough competition with already approved other players!
  • Mochida – Enbrel BS- first to file for Japan, now equipped with full basket for being one of the top biosimilar player in Japan
  • Mitsubishi Tanabe –Not in biosimilars area yet
  • MGC Pharma (now as Cultivec) – A Bio-pharmaceutical CMO- leveraging the findings gained through developing the mass-culture technology to develop biosimlars!
  • Nichi-Iko – Aspiring to capture overseas markets, committed to the biosimilar business in the US
  • Nipro Pharma – Not much development after Somatropin BS
  • Nippon Kayaku – Pioneering ?New Age’ of biosimilars: After Remicade- now launch of Herceptin BS is key
  • Sawai – Intends to establish sales team in biosimilar field in next few years
  • Towa – Still waiting for Government right policy pitch for biosimilar
  • Toyobo Biologics - Eying at biosimilars CMO Business
  • Takeda Teva Pharmaceuticals – Noclarity on biosimilar launch plan in Japan
  • UMN Pharma – Transforming vaccines heritage into new generation biologics- but no major progress in last couple of years in biosimilar area
  • Yoshindo – A steady progress for Enbrel biosimilar- “Three step” approach to build a Bio Company
  • Sanwa Kagaku – NESP biosimilar – a therapy focus biosimilar entry for Japan market
  • Amgen – Timely launch is key through Daiichi Sankyo Partnership in Japan
  • Chong Kun Dang – With Fuji Pharma entering in NESP BS market


List of Figures


CHART 1: ANEMIA DYNAMIC MARKET IN JAPAN (2017-2019)
CHART 2: NEUTROPENIA MARKET DYNAMICS
ANNEXURE: - I YEAR WISE PARTNERSHIP IN BIOSIMILAR SPACE IN JAPAN
ANNEXURE: - II BIOSIMILAR GUIDELINES ADOPTED BY VARIOUS COUNTRIES
ANNEXURE:-III ACTIVE FOREIGN COMPANIES IN BIOSIMILAR SPACE- JAPAN
 

List of Tables


TABLE NO TABLE NAME
TABLE 1: JP BIOSIMILAR COMPETITIVE LANDSCAPE (A)
TABLE 2: OPENING OPPORTUNITIES - EARLY WAVE BIOSIMILARS (B)
TABLE 2: OPENING OPPORTUNITIES - NEXT WAVE BIOSIMILARS (C)
TABLE 3: CO-PAY SLABS IN JAPAN
TABLE 4: LAUNCHED BIOSIMILARS IN JAPAN- UPTAKE VARIES FOR EACH BIOSIMILARS
TABLE 5: APPROVED BIOSIMILARS IN JAPAN
TABLE 6: DATA PACKAGE OF SOMATROPIN BIOSIMILAR APPROVAL
TABLE 7: DATA PACKAGE OF EPOETIN ALFA BIOSIMILAR APPROVAL
TABLE 8: ANEMIA MARKET DYNAMICS: REPORTED SALES FOR FY2017, FY2018 & FY2019
TABLE 9: DARBOPOETIN ALFA: BIOSIMILARS AND BIOSAME
TABLE 10: FILGRASTIM BS - LOCAL VS. OVERSEAS CLINICAL STUDIES SUBMITTED
FOR JP APPROVAL BY EACH PLAYER
TABLE 11: MOCHIDA FILGRASTIM BS - CLINICAL STUDIES SUBMITTED FOR JP APPROVAL
TABLE 12: NIPPON KAYAKU FILGRASTIM BS – DETAIL STUDIES SUBMITTED FOR
JP APPROVAL
TABLE 13: SANDOZ – JAPAN FILGRASTIM “BS” - DETAIL STUDIES SUBMITTED
FOR JP APPROVAL
TABLE 14: SANDOZ – JAPAN FILGRASTIM “BS” - OVERSEAS STUDIES SUBMITTED
FOR JP APPROVAL
TABLE 15A: FILGRASTIM/GRAN, COMPETITIVE LANDSCAPE- MARKET STRATEGY
OF EACH PLAYER
TABLE 15B: FILGRASTIM/GRAN/G-LASTA- SALES TREND OF EACH NEUTROPENIADRUG IN JAPAN
TABLE 16: DATA PACKAGE OF INFLIXIMAB BS
TABLE 17: CLINICAL DATA SUBMITTED FOR JP APPROVAL OF REMICADE
BIOSIMILAR
TABLE 18: CLINICAL DATA COMPARISON OF CT- P13 VS. INX IN RA
TABLE 19: CLINICAL STUDIES SUBMITTED FOR ELI-Lilly LANTUS BS APPROVAL IN JAPAN
TABLE 20: CLINICAL STUDIES SUBMITTED FOR FUJIFILM-BIOCON LANTUS BS APPROVAL IN JAPAN
TABLE 21: OTHER KEY BIOSIMILAR OPPORTUNITIES IN INSULIN AREA IN
JAPAN
TABLE 22: ETANERCEPT COMPETITIVE LANDSCAPE
TABLE 23: ORIGINATOR’S APPROVED INDICATION AND DOSING SCHEDULE
TABLE 24: COMPETITIVE LANDSCAPE WITH DETAILS OF THE CLINICAL
STUDIES SUBMITTED FOR HERCEPTIN BIOSIMILAR
TABLE 25: AVASTIN BIOSIMILARS–LAUNCHED & PIPELINE
TABLE 26: KEY RA BIOLOGICS SALES TREND JAPAN 2014-2019
TABLE 27: HUMIRA BIOSMILAR COMPETITATIVE LANDSCAPE
TABLE NO TABLE NAME
TABLE 1: JP BIOSIMILAR COMPETITIVE LANDSCAPE (A)
TABLE 2: OPENING OPPORTUNITIES - EARLY WAVE BIOSIMILARS (B)
TABLE 2: OPENING OPPORTUNITIES - NEXT WAVE BIOSIMILARS (C)
TABLE 3: CO-PAY SLABS IN JAPAN
TABLE 4: LAUNCHED BIOSIMILARS IN JAPAN- UPTAKE VARIES FOR EACH BIOSIMILARS
TABLE 5: APPROVED BIOSIMILARS IN JAPAN
TABLE 6: DATA PACKAGE OF SOMATROPIN BIOSIMILAR APPROVAL
TABLE 7: DATA PACKAGE OF EPOETIN ALFA BIOSIMILAR APPROVAL
TABLE 8: ANEMIA MARKET DYNAMICS: REPORTED SALES FOR FY2017, FY2018 & FY2019
TABLE 9: DARBOPOETIN ALFA: BIOSIMILARS AND BIOSAME
TABLE 10: FILGRASTIM BS - LOCAL VS. OVERSEAS CLINICAL STUDIES SUBMITTED
FOR JP APPROVAL BY EACH PLAYER
TABLE 11: MOCHIDA FILGRASTIM BS - CLINICAL STUDIES SUBMITTED FOR JP APPROVAL
TABLE 12: NIPPON KAYAKU FILGRASTIM BS – DETAIL STUDIES SUBMITTED FOR
JP APPROVAL
TABLE 13: SANDOZ – JAPAN FILGRASTIM “BS” - DETAIL STUDIES SUBMITTED
FOR JP APPROVAL
TABLE 14: SANDOZ – JAPAN FILGRASTIM “BS” - OVERSEAS STUDIES SUBMITTED
FOR JP APPROVAL
TABLE 15A: FILGRASTIM/GRAN, COMPETITIVE LANDSCAPE- MARKET STRATEGY
OF EACH PLAYER
TABLE 15B: FILGRASTIM/GRAN/G-LASTA- SALES TREND OF EACH NEUTROPENIADRUG IN JAPAN
TABLE 16: DATA PACKAGE OF INFLIXIMAB BS
TABLE 17: CLINICAL DATA SUBMITTED FOR JP APPROVAL OF REMICADE
BIOSIMILAR
TABLE 18: CLINICAL DATA COMPARISON OF CT- P13 VS. INX IN RA
TABLE 19: CLINICAL STUDIES SUBMITTED FOR ELI-Lilly LANTUS BS APPROVAL IN JAPAN
TABLE 20: CLINICAL STUDIES SUBMITTED FOR FUJIFILM-BIOCON LANTUS BS APPROVAL IN JAPAN
TABLE 21: OTHER KEY BIOSIMILAR OPPORTUNITIES IN INSULIN AREA IN
JAPAN
TABLE 22: ETANERCEPT COMPETITIVE LANDSCAPE
TABLE 23: ORIGINATOR’S APPROVED INDICATION AND DOSING SCHEDULE
TABLE 24: COMPETITIVE LANDSCAPE WITH DETAILS OF THE CLINICAL
STUDIES SUBMITTED FOR HERCEPTIN BIOSIMILAR
TABLE 25: AVASTIN BIOSIMILARS–LAUNCHED & PIPELINE
TABLE 26: KEY RA BIOLOGICS SALES TREND JAPAN 2014-2019
TABLE 27: HUMIRA BIOSMILAR COMPETITATIVE LANDSCAPE

TABLE 28: OTHER NICHE OPPORTUNITIES IN OPHTHALMIC/ONCO/
AUTOIMMUNE THERAPY AREA
TABLE 29: MAJOR BIO-CMO COMPANIES IN THE WORLD AND THEIR ACTIVITIES
IN JAPAN
TABLE 30: MAJOR BIO-CMO COMPANIES IN JAPAN
TABLE 31: FUJI FILM KYOWA KIRIN BIOLOGICS- BIOSIMILAR PIPELINE
TABLE 32: GENE TECHNO SCIENCE-BIOGENERICS STATUS
TABLE 33: JCR -APPROVED PRODUCTS
TABLE 34: MSP - BIOSIMILAR PIPELINE
TABLE 35: MOCHIDA -BIOSIMILARS - MARKETED PRODUCTS AND PIPELINE
TABLE 36: NICHI- IKO - BIOSIMILARS -MARKETED PRODUCTS AND PIPELINE
TABLE 37: NIPPON KAYAKU - BIOSIMILAR STATUS
TABLE 38: AMGEN/DAIICHI SANKYO - BIOSIMILARS–LAUNCHED & PIPELINE