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 tmake Biosimilar friendly market environment in Japan by Payers and Players “Abenomics” initiatives tPromote BS use- Recent “Honebuto” aim for achievable FY2020 plan BS use must tcurb healthcare cost- A forward Pressure on “Chuikyo”? – Tmake 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 tfollow Uptake of Filgrastim and Lantus BS in Japan – - A slow start of Remicade BS “NK”- Not withstanding Nippon Kayaku tenrich 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- 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 Regulatory/Development investment - JP dosage strength of originator vs. US dosage strength of Originator JP Market size and Reimbursement/NHI Price of Originator Expected nof players in biosimilar space in Japan, Innovator strategy in Japan, Re-examination period expiry Key challenges for each biosimilar opportunities in Japan - Niche BS opportunities in Japan - Factors driving Biosimilar penetration in Japan – Government incentives tprescribe “BS” is key
Chapter 2: Japanese Government And “Chuikyo” Initiatives TIncrease 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 tcounteract with proposed change in reimbursement policy Authorised biosimilar entry Prescribing BS with Generic name or Brand-? Cost of development- Bridging study? Multinational trials? - DPC hospitals- One of the tool of Government tincrease 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 tgrow like EU and Now NESP patent expiry in 2018-2019 will unlock bigger opportunity.
Chapter 4: Filgrastim (Gran) Bs: Now Focus Shift TPegfilgrastim 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 tOriginator- Impact on NHI reimbursement price tbiosimilar - 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 tJapan” on Filgrastim BS market share dynamics post twyears of launch
Chapter 5: Remicade BS - Nichi IkRemicade Bs Launch By Ye2017- Will Help In TRemicade Bs Overall PenetrationIncluding 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? Details of clinical studies submitted for Remicade biosimilar “NK” approval PMS studies and label of Remicade BS NHI reimbursement price tRemicade biosimilar- Role of JP clinical studies 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 Remicade use in DPC hospitals Remicade biosimilar use may reduce working capital of hospitals tsome extent - Competitive landscape of Remicade biosimilar- Nippon Kayaku’s entry in RA market 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 nof 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 tbe a first entrant with Kyowa HakkKirin hematology field strength, Herceptin Biosimilar- Next opportunity after Rituximab BS, Perjeta and Kadcyla uptake still makes it interesting opportunity Niche opportunity in Autoimmune/ Onctherapy area, Big Oncology Focused Japanese Pharma Giants- Dthey follow AZN type of product specific BS deal- tstrengthen 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 CMOpportunity - CMneed for biosimilar business - Current status of domestic biosimilar CMmarket in Japan
Chapter- 9 Regulatory Approval Requirement For Complex Mab Biosimilar In Japan - Key take away of JP biosimilar guideline when compared tEU/US requirement - JP Requirement: Reference Product, Using oversea product as reference product: As per updated 2015 guideline: - JP Requirement: Interchangeability/Substitution, Evaluation test on equivalence / homogeneity on quality characteristics - JP Requirement: Clinical trials - JP Requirement: Pharmacovigilance It is reasonable treport the progress of past marketing surveillance at the planned time and not only at the end of the survey - JP Requirement: PMS for Biosimilar Somatropin BS Epoetin Alfa BS Filgrastim 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-Ikhas global plan in place - In past, Japanese generic players were reluctant tenter in BS market due thefty development cost - Japanese conglomerate venturing intGlobal bio-CDMbusiness through acquiring Ex-Japan assets.
Select Japanese Companies Active IntBiogenerics Space Aska Pharmaceuticals - Barriers tGain from Partner’s Pipeline Asahi Glass – Entering in BioPharma CMbusiness for Global Market Chugai Pharmaceuticals- Authorized biosimilar is a strategy tprotect? Daiichi Sanky– 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 TechnScience- 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 twatch! But silent for Enbrel and Herceptin biosimilar development through Alteogen, Focus tbe a niche player in BS space Kyowa HakkKirin – NESP authorized biosimilar strategy- a smart move! Partnership for Humira BS for EU market- next twatch, Sandoz Partnership for Rituximab BS commercialization- strengthen its Hematology Presence Meiji Seika Pharma (MSP) – Trastuzumab biosimilar launch awaited in Japan! Mochida – Enbrel BS –first tfile for Japan! Mitsubishi Tanabe – Need a close watch for Yakult BS JV! MGC Pharma- A Bio-pharmaceutical CM– now as Cultivec! Nichi-Ik– A DPC hospital focused biosimilar launch in making! NiprPharma – Yet tcome 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 testablish sales team in Biosimilar field in next few year Towa – Still waiting for Government right policy pitch for biosimilar ToyobBiologics - Eying at Biosimilars CMBusiness Takeda Teva Pharmaceuticals – Opportunity for generic and off patent medicines- May enter in BS space UMN Pharma - Transforming Vaccines Heritage intNew Generation Biologics but Nmajor progress in last couple of years in biosimilar area Yoshind– A steady progress for Enbrel biosimilar- “Three step” approach tbuild a BiCompany Sanwa Kagaku - NESP biosimilar – a therapy focus biosimilar entry for Japan market Amgen – Timely launch is key through Daiichi SankyPartnership 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-CMcompanies in the world and their activities in Japan Table 28: Major Bio-CMcompanies in Japan Table 29: FujiFilm Kyowa Kirin Biologics Biogenerics Pipeline Table 30: Gene TechnScience- 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
Write comment about above report:
Published By: MP Advisors
Did you find what you are/were looking for
If not, read below and browse through other relevant pages for similar market research
reports OR get in touch with us through the form/contact info in your right navigation
panel and well share relevant market report titles for you to explore.
We are on:
500,000 market research reports and growing.
Top Fortune 500 Organizations trust us for research data.
24/7 support on call as well as emails.
Your Details are safe with us.
Free support for your research requirements.
Report Delivery: Email
Upto 24 hrs - working days
Upto 48 hrs max - weekends and public holidays
Buy Any Report Avail 20% Discount. Coupon Code: DEC20
Connect for special KNOWLEDGE STORE Deals Subscription starts at $ 20K