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
• Fadriving 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
• 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