Japan Biosimilars – A start of Authorized Biosimilar Era? Biosimilar/BioPharma CMO opportunities – JP Conglomerates – A definite role to play for Global Market! Major JP Innovator vs. Early entrant Mid size Japanese companies- TA focus approach – A Win Win Game!

In 2016, encouraging uptake of Lantus BS in Japan confirms strong foothold of the marketer, product mix targeted to DPC hospitals (Diagnostic Procedure Combination hospitals- ~4000) and early entry of the player are critical factors to decide biosimilar penetration and market share dynamics of Japan Biosimilar Market. While ongoing discussion of local originators to launch authorized generic BS in a way indicate cost pressure & threat on the originators by payers(Chuikyo), but put pause on attractiveness of developing BS for a mid size & generic pharma players. Small molecule authorized generics launch in Japan (Blopress- Aska, Plavix-Nichi Iko.) in last few years took major market share amongst generic players (>50%).
 
 On the contrary, Biologics contribute significant part of the current healthcare spend (17% of total healthcare spend) by government in Japan. As the growth rate of drug cost are higher than the growth rate of the overall health care costs in Japan, and biologics are one of the major contributor to that- to reduce healthcare burden, a biosimilar weapon is a must need in Japan. As per the recent survey of RA market in Japan amongst patient and Prescribers, ~40% of the patients/prescribers not used biologics to treat RA as it is expensive. To address these challenges and to make biosimilar development/use friendly environment, initiative to form JBSA (Japan biosimilar Association) has been in place in 2016. Separately, Government recent “Honebuto” Policy aims to double Biosimilar API by 2020 from Current (5 to 10), again confirms JP Government stands to aggressively push biosimilars use in Japan.
 
 JBSA has done on the ground survey to handle Biosimilar penetration challenges and we expect this to result in government definite direction for efficient biosimilar development in Japan around 2018 with institutional reforms. This may include remunerating prescribers/pharmacy/hospitals to use biosimilar, removing high cost medical care benefit system for increasing biosimilar penetration in Japan. High cost medical care benefit programme and various Government public Insurance programmes minimize the benefits of “co-pay difference” associated with biosimilar use. We expect evident change in these programmes in next NHI price revision to push prescribers/DPC hospitals to increase use for biosimilar in Japan.
 Globally, a definite positive directions from USFDA to approve Biosimilars in US, recent success of Immuno Oncology Mabs on Innovation front and a steep uptake of these drugs in the Japan market, increased confidence of Japanese giants for more biopharma success in the coming time vs. small molecule to get breakthrough to grow. These has allowed Japanese conglomerates to venture in global biologics CMO space in recent times (Asahi-Kasei – CMC biologics) and more M & A is expected in this direction to fulfill the gap of Biopharma-MAb technology platforms amongst Japanese Players.
 
 Based on the FY2016 sales reported by major biopharma drugs in Japan- Biosimilars are an opportunity of cumulative market size of ¥630b (Table 3) in next few years for Japan biosimilar players.
 
 In this report, we attempt to evaluate key upcoming opportunity for Japan BS market, its competitive landscape, and current trend of biosimilars use in Japan. It also details Japanese “Chuikyo” (Central and Social Regulatory Council) stand for Biosimilar penetration and regulatory approval requirement for non- JP specific dosage strength or/has clinical data from Ex-Japan clinical trial. The report provide all the Japanese/Global players’ activities in biosimilar space for Japan market along with their pipeline deal history, current Mab tech platforms, alliances and deal structure. It details crisp summary on strategies of each key player (~36 JP local companies, multinational companies), their interest & focus for future collaboration in biosimilar space.

CHAPTER 1: EXECUTIVE SUMMARY
 

 • Formation of JBSA - A start point to make Biosimilar friendly market environment in Japan by Payers and Players
 o “Abenomics” initiatives to Promote BS use- Recent “Honebuto” aim for achievable FY2020 plan
 o BS use must to curb healthcare cost- A forward Pressure on “Chuikyo”? – To make Japan early than US in approving “MAb” biosimilar - at What Price?
 • Authorised Biosimilars- Would it repeat Authorised Generic story of Japan and a threat for mid size JP companies for Biosimilar development?
 • Next candidates to follow Uptake of Filgrastim and Lantus BS in Japan –
 • A slow start of Remicade BS “NK”- Not withstanding Nippon Kayaku to enrich its pipeline with other BS drugs
 • Upcoming next opportunities in biosimilar space in Japan Wave 2 (2018-2020) and Wave 3 (Post 2020)- beyond key Onco/RA drugs
 • Licensing activities in biosimilar space in Japan-
 o Current Status of pipeline of Each Active companies in BS space:
  What is in and what is left or broken?
  Some are still in dilemma for entering??
  Most of companies have cherry picked couple of biologics from full basket
 • Launch timeline and Our view on Each potential key opportunity in Biosimilar space in Japan based on
 o Regulatory/Development investment - JP dosage strength of originator vs. US dosage strength of Originator
 o JP Market size and Reimbursement/NHI Price of Originator
 o Expected no of players in biosimilar space in Japan, Innovator strategy in Japan, Re-examination period expiry
 o Key challenges for each biosimilar opportunities in Japan
 • Niche BS opportunities in Japan
 • Factors driving Biosimilar penetration in Japan – Government incentives to prescribe “BS” is key
 
 CHAPTER 2: JAPANESE GOVERNMENT AND “CHUIKYO” INITIATIVES TO INCREASE BIOSIMILAR PENETRATION IN JAPAN- IN LINE WITH RECENT “HONEBUTO”
 

 JBSA- How it will play important role for Biosimilar Penetration in Japan and overcome BS penetration related issues?
 • JBSA- Formation, Objectives, Agenda
 • Identified key challenges for BS penetration in Japan & Plan to counteract with proposed change in reimbursement policy
 o Authorised biosimilar entry
 o Prescribing BS with Generic name or Brand-?
 o Cost of development- Bridging study? Multinational trials?
 • DPC hospitals- One of the tool of Government to increase BS penetration
 
 CHAPTER 3:– GROWTH HORMONE & ERYTHROPOIETIN- LESSONS FROM LAUNCHED BIOGENERIC PROGRESS IN JAPAN SINCE 2009
 
 
• EPO- Anemia Market in Japan- Market forces allow this biosimilar market to grow like EU and Now NESP patent expiry in 2018-2019 will unlock bigger opportunity.
 
 CHAPTER 4: FILGRASTIM (GRAN) BS: NOW FOCUS SHIFT TO PEGFILGRASTIM BS DEVELOPMENT- POSSIBILITY OF KHK‘S AG OF G-LASTA- A BLOW FOR OTHER PLAYERS?
 
 
1. NHI reimbursement pricing – Trends for GRAN biosimilar & G-LASTA pricing
 • % price cut to Originator- Impact on NHI reimbursement price to biosimilar
 • For Sandoz, Late entry did not result in any NHI reimbursement price disadvantage???-Implications
 2. Dosage strength comparison of Filgrastim BS vs. GRAN BS-
 3. What type of Bridging study done by Sandoz for JP approval of its Ex-Japan approved Filgrastim BS?
 Filgrastim biosimilar Japan – Facing Challenges with launch of G-Lasta (Pegfilgrastim) by Innovator? G-Lasta (Pegfilgrastim) launch by KHK in Japan- Mainly Cannibalized Gran
 Observed Impact Post three years of Launch in Crowded Filgrastim BS market- Impact of “Made & Tested in Japan” vs. “Imported to Japan” on Filgrastim BS market share dynamics post two years of launch
 
 Chapter 5: REMICADE BS - NICHI IKO REMICADE BS LAUNCH BY YE2017- WILL HELP IN TO REMICADE BS OVERALL PENETRATION INCLUDING REMICADE BS “NIPPON KAYAKU”
 
 
Findings from JP approval and Launch of First complex mAb - Remicade biosimilar “NK” in Japan
 • Extrapolation of Indication expansion- possible or not? What studies needed/submitted?
 o Details of clinical studies submitted for Remicade biosimilar “NK” approval
 o PMS studies and label of Remicade BS
 o NHI reimbursement price to Remicade biosimilar- Role of JP clinical studies
 o Originator NHI Price cut in April -16 Price Revisions - what was the impact on Remicade BS?
 • Role of PhIII study in respective indications- Only RA study is carried out
 • Remicade use in hospitals
 o Remicade use in DPC hospitals
 o Remicade biosimilar use may reduce working capital of hospitals to some extent
 • Competitive landscape of Remicade biosimilar-
 o Nippon Kayaku’s entry in RA market
 o Nichi-Iko’s late entry – but with double sword of marketing tie up with ‘Ayumi’
 
 Chapter 6- LANTUS BIOSIMILAR- ONE OF THE MOST SUCCESSFUL BS LAUNCH IN JAPAN- COMPETITION INTENSIFY AFTER FUJIFILM BIOCON LANTUS BS LAUNCH IN 2016
 
 
Early uptake of LLY BS ENCOURAGING-
 Regulatory studies submitted for Lantus BS approval in Japan by Eli-Lilly & FujiFilm Biocon –
 • NHI reimbursement pricing of Lantus BS in Japan
 • Early uptake encouraging and better than EU- Probable reasons??
 • Competitive Landscaped in Japan- Fujifilm Biocon Lantus BS recent launch
 • Other Insulin Biosimilar opportunities in Japan
 
 Chapters 7- NEXT WAVE OF BIOSIMILAR OPPORTUNITIES IN JAPAN
 
 
NESP BIOSIMILAR -
 • Unique Niche Opportunity targeting DPC hospital
 • Current Competitive landscape
 • AG of NESP by KHK
 
 AUTOIMMUNE BIOSIMILARS: JP Specific Opportunity other than key complex RA MAB - Market Share Differ for Key RA Mab vs. WW for key players
 
• Enbrel BS – Next opportunity in RA space after Remicade, Mochida-LG will be the First entrant
 • Humira -a limited no of players in Japan? - Probable Reasons
 • Actemra and Cimzia- Opportunities beyond 2020 and more attractive?
 Market dynamics will be different for Remicade/Enbrel/Humira biosimilar despite targeting similar key markets.
 
 ONCOLOGY BIOSIMILARS: Era starts with expected launch of Rituximab Biosimilar in 2017/2018 in Japan followed by Herceptin and Avastin biosimilar in 2018/19.
 
Rituximab biosimilar opportunity- Sandoz looks to be a first entrant with Kyowa Hakko Kirin hematology field strength,
 Herceptin Biosimilar- Next opportunity after Rituximab BS, Perjeta and Kadcyla uptake still makes it interesting opportunity
 Niche opportunity in Autoimmune/ Onco therapy area, Big Oncology Focused Japanese Pharma Giants- Do they follow AZN type of product specific BS deal- to strengthen their Oncology NCE franchisee?
 Patent expiry (Indication wise JP patents, Reexamination period expiry) and Competitive Landscape of Oncology biosimilar in Japan-
 Chapter -8 BIOSIMILAR/BIOPHARMA CMO OPPORTUNITY
 • CMO need for biosimilar business
 • Current status of domestic biosimilar CMO market in Japan
 
 Chapter- 9 REGULATORY APPROVAL REQUIREMENT FOR COMPLEX MAB BIOSIMILAR IN JAPAN
 
 
• Key take away of JP biosimilar guideline when compared to EU/US requirement
 • JP Requirement: Reference Product,
 o Using oversea product as reference product: As per updated 2015 guideline:
 • JP Requirement: Interchangeability/Substitution,
 o Evaluation test on equivalence / homogeneity on quality characteristics
 • JP Requirement: Clinical trials
 • JP Requirement: Pharmacovigilance
 o It is reasonable to report the progress of past marketing surveillance at the planned time and not only at the end of the survey
 • JP Requirement: PMS for Biosimilar
 o Somatropin BS
 o Epoetin Alfa BS
 o Filgrastim
 o Remicade
 • Label for biosimilar in Japan
 
 CHAPTER 10: LICENSING/CONSOLIDATION ACTIVITIES IN BIOSIMILAR SPACE IN JAPAN-
 
• Japanese giants entering in biosimilar space either through Authorized biosimilar vehicle or by collaborating with biotech MNC on broad way
 • Local domestic major Japanese companies- few of them are bracing for wave 2 biosimilar, while Nichi-Iko has global plan in place
 • In past, Japanese generic players were reluctant to enter in BS market due to hefty development cost
 • Japanese conglomerate venturing into Global bio-CDMO business through acquiring Ex-Japan assets.
 
 SELECT JAPANESE COMPANIES ACTIVE INTO BIOGENERICS SPACE
 
Aska Pharmaceuticals - Barriers to Gain from Partner’s Pipeline
 Asahi Glass – Entering in BioPharma CMO business for Global Market
 Chugai Pharmaceuticals- Authorized biosimilar is a strategy to protect?
 Daiichi Sankyo – Amgen partnership makes it a front runner! Enbrel drop plan- Failure of Coherus Bioscience deal
 Fuji Film Kyowa Kirin Biologics (FF-KKB) - Looking beyond Domestic Opportunities- First step in that direction by FKB238JV with AstraZeneca
 Fuji Pharma- Dynamic Specialty Pharma Focusing on Biosimilars
 Gene Techno Science- JP Biopharma rising star- LaunchPad12, regenerative medicines & many more…! Developing new biopharmaceuticals and biosimilar
 Itochu Chemical Frontier Corporation- A trading house with new role in Biosimilar value chain
 JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners- Now thrive in Regenerative Medicine & fast tracking NESP biosimilar
 Kissei – Timely launch of NESP biosimilar – Next to watch! But silent for Enbrel and Herceptin biosimilar development through Alteogen, Focus to be a niche player in BS space
 Kyowa Hakko Kirin – NESP authorized biosimilar strategy- a smart move! Partnership for Humira BS for EU market- next to watch, Sandoz Partnership for Rituximab BS commercialization- strengthen its Hematology Presence
 Meiji Seika Pharma (MSP) – Trastuzumab biosimilar launch awaited in Japan!
 Mochida – Enbrel BS –first to file for Japan!
 Mitsubishi Tanabe – Need a close watch for Yakult BS JV!
 MGC Pharma- A Bio-pharmaceutical CMO – now as Cultivec!
 Nichi-Iko – A DPC hospital focused biosimilar launch in making!
 Nipro Pharma – Yet to come after Somatropin BS
 Nippon Kayaku - Pioneering ‘New Age’ Of Biosimilars after Remicade- Now Launch of Herceptin BS is key
 Sawai – With Filgrastim BS Launch intends to establish sales team in Biosimilar field in next few year
 Towa – Still waiting for Government right policy pitch for biosimilar
 Toyobo Biologics - Eying at Biosimilars CMO Business
 Takeda Teva Pharmaceuticals – Opportunity for generic and off patent medicines- May enter in BS space
 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
  


List Of Tables

 Table 1: JP Biosimilar opportunities – Competitive Landscape- Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges
 Table 2: Other Key JP Specific Opportunities – Wave 2 and Wave 3 Opportunities
 Table 3: Opening Opportunities in Biosimilar Space
 Table 4: Japanese Companies in the Biosimilar Space
 Table 5: Co-Pay slabs in Japan
 Table 6: Pricing of Key biologics in Japan
 Table 7: Launched Biosimilar in Japan- Uptake Varies per Therapy area
 Table 8: Anemia Market Dynamics: Erythropoietin Reported Sales in FY2017
 Table 9: Filgrastim BS- Local vs. Overseas Clinical studies submitted for JP approval by each Player
 Table 10: Mochida Filgrastim BS – Clinical Studies submitted for JP Approval
 Table 11: Nippon Kayaku Filgrastim BS – Detail Studies Submitted for JP Approval
 Table 12: Sandoz Filgrastim BS – Detail Studies submitted for JP Approval
 Table 13a: NHI Reimbursement Pricing trend of GRAN and G-LASTA
 Table 13b: NHI Reimbursement Pricing trend of GRAN /FILGASTRIM Biosimilar
 Table 14a: Filgrastim/Gran, Competitive Landscape- Market Strategy of each player
 Table 14b: Filgrastim/Gran/G-LASTA- Sales Trend of Each Neutropenia drug in Japan
 Table 15: Clinical Data Submitted for JP approval of Remicade Biosimilar
 Table 16: Clinical Data Comparison of CT-P13 vs. INX in RA
 Table 17: Japan Lantus, Lantus XR and Insulin Glargine “BS”- Dosage Strength/NHI Price
 Table 18: Lantus BS - Discount provided in Japan/EU market post Launch
 Table 19a: Clinical studies submitted for Lantus BS approval in Japan of Eli-Lilly
 Table 19b: Clinical studies submitted for Lantus BS approval in Japan of FujiFilm-Biocon
 Table 20: Other Key Biosimilar Opportunities in Insulin area in Japan
 Table 21: Key RA Biologics sales Trend Japan 2011-2016
 Table 22: Other Niche Opportunities in Onco/Autoimmune therapy area
 Table 23: Japan IP landscape of Key biosimilars focusing on autoimmune Disease
 Table 24: Japan competitive landscape of key biosimilars focusing on autoimmune disease
 Table 25: Japan IP landscape of key biosimilars focusing on oncology disease
 Table 26: Japan competitive landscape of key biosimilars focusing on oncology disease
 Table 27: Major Bio-CMO companies in the world and their activities in Japan
 Table 28: Major Bio-CMO companies in Japan
 Table 29: FujiFilm Kyowa Kirin Biologics Biogenerics Pipeline
 Table 30: Gene Techno Science- Biogeneric Status
 Table 31: JCR: Pipeline
 Table 32: JCR : Approved Products
 Table 33: MSP- Biogenerics Pipeline
 Table 34: Mochida- Marketed Products and Pipeline
 Table 35: Nichi-Iko- Biogenerics Pipeline of Biosimilars
 Table 36: Nippon Kayaku- Biogeneric Status


List Of Figures

 
 Chart 1 : Anemia Market Dynamics Trend Of Market Share In 2016-2017
 Chart: 2 - Neutropenia Market Dynamics
 Chart: 3 - RA Biologics Market Dynamics 12 Month Cumulative Market Share

 Companies Mentioned

 Aska Pharmaceuticals,
 Asahi Glass,
 Chugai Pharmaceuticals,
 Daiichi Sankyo,
 Fuji Film Kyowa Kirin Biologics (FF-KKB),
 Fuji Pharma, Gene Techno Science,
 Itochu Chemical Frontier Corporation,
 JCR Pharmaceuticals:,
 Kissei,
 Kyowa Hakko Kirin,
 Meiji Seika Pharma (MSP),
 Mochida,
 Mitsubishi Tanabe,
 MGC Pharma,
 Nichi-Iko,
 Nipro Pharma,
 Nippon Kayaku
  Sawai,
 Towa,
 Toyobo Biologics,
 Takeda Teva Pharmaceuticals,
 UMN Pharma,
 Yoshindo,
 Sanwa Kagaku,
 Amgen


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