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Japan Biosimilar- Active Players In Quest of a Specialty & Niche BS space

Japan Biosimilar- Active Players In Quest of a Specialty & Niche BS space

Filgrastim BS and Lantus BS Approval- Encouraging uptake and a lesson to fast track JP approval based on Ex-Japan data! Remicade biosimilar “NK” – A slow start does not pull back NK in starting PhIII for Herceptin BS in JapanActive companies in Biosimilar Space: Local Japanese Generic Giants- Opening door for Biosimilars in Japan? - Will go for All or Niche in BS space???- Opportunities beyond 2020?

Encouraging Uptake of Filgrastim BS and Lantus BS in 2015 in Japan is indicative of Japan being a key important market after the EU for growth of Biosimilar players in the next five years. Less stringent regulatory environment vs. US for approval, increasing healthcare burden and strong foothold of the marketers have played key roles in this early uptake which is at par to one of the best generic small molecule penetration in Japan in a short time (Filgrastim BS-volume share~45% in two years, Lantus BS- ~9% in 2 months vs. Lipitor generics ~50% volume share). In contrast, there is a very slow uptake of Remicade Biosimilar post one year launch (~1% volume share). Biosimilars remains to be the key weapon to curb increasing healthcare cost in Japan & there is a forward pressure on Chuikyo (Central social Insurance Medical Council) by Zaimu-sho (Ministry of Finance- Japan) to increase use of biosimilars. We see that Abenomics measures and government involvement in biosimilar use would lead to the same type of progress for complex mAb Biosimilars in the coming times in JapanThe launch of Sandoz EU approved dosage form of Filgrastim BS in Japan, and Lantus BS based mainly on foreign studies (only one PhIII study involved JP patients from the eight studies submitted for approval) along with Celltrion-NK Remicade biosimilar in 2014/2015 in the Japan pharma market demonstrated more flexibility for EU- Ex-Japan data by JP regulatory authorities for a biosimilar approval and a less stringent path vs. US for BS approval. Biosimilar of Complex mAb structure is an opportunity of cumulative market size of ¥300b in the next three years in Japan. It will open doors for first oncology biosimilar mAb in Japan after Remicade BS launch in 2014, while in next 7 years it is cumulative ¥600b market opportunity for biosimilar players.

While analyzing the launched biosimilar penetration since 2009 launch in Japan (Growth hormone, Erythropoietin, G-CSF), use of the product in DPC hospitals, simple protein moiety and product reimbursement under high cost medical care benefit programme of NHI/JP government are the key JP specific factors which decide uptake timeline and penetration of each biosimilar in Japan. Since the last five years, most of the companies have some alliance in place for biosimilars, with most of the Japanese companies undertaking pacts with South Korean companies to ride on their back of biosimilar mAb expertise. There is a trend of doing product specific alliance by most of the JP companies active in BS space and to go step by step on this high risk/high return opportunities. Overall, in the Japan market, each opportunity has a different competitive landscape for itself, and some companies are looking for niche opportunities in biosimilar space as per their specialty therapy area- like ophthalmology BS (Lucentis), Enzyme therapy BS (JCR) In this report, we attempt to analyze trend/requirement of regulatory approval of biosimilars based on Ex-Japan clinical trial data, Factors responsible for each key launched biosimilar penetration (“Made in Japan” vs. “Tested by Japan”), and the future competitive landscape in the biosimilars space in Japan. We also attempt to analyze detail BS market of EPO, Filgrastim/Pegfilgrastim/ Insulin/Lantus apart from other key complex Mab Biosimilar opportunities and list out niche opportunities in biosimilar space in Japan. It details all major consolidation activities done by JP/Foreign companies in biosimilar space in the last five years and crisp summary on strategies of each key player (~21 JP local companies, multinational companies), their interest & focus for future collaboration in biosimilar space.

Biosimilars (BS) – One of the key weapons for Government to curb healthcare cost in Japan
Uptake of Filgrastim and Lantus BS in Japan - Better than Small molecule generics—Key reasons
A slow start of Remicade BS “NK”- Will it change in near term or take time?
“Abenomics” initiatives to Promote BS use- How will it change the current scenario?
BS use must to curb healthcare cost- A forward Pressure on “Chukiyo”?- Japan early than US in approving “mAb” biosimilar- at What Price?
Upcoming next opportunities in biosimilar space in Japan beyond key Onco/RA drugs and Post 2020…
Licensing activities in biosimilar space in Japan-
Current Status of pipeline of Each Active company in the BS space:
What is in and what is left?
Are some still in the dilemma of entering the BS space??
Most of the companies have cherry picked couple of biologics from the 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 no. of players in the biosimilar space in Japan, Innovator strategy in Japan, Re-examination period expiry
Key challenges for each biosimilar opportunity in Japan
Niche BS opportunities in Japan
Factors driving biosimilar penetration in Japan – Government incentives to prescribe “BS” is key.
JP specific factor-
Use in DPC hospitals
Reimbursement under high cost medical care Government benefit programme.
Price difference for small molecule generic use vs. biologic - how big role it will play for biosimilar penetration?
Therapy Specific Factor-
Acute vs. Chronic/ Pediatric vs. Adult
Support therapy vs. treatment therapy
Physician experience of using class of therapy drugs…
Table 1: Summary Table –Originator JP Dosage strength, Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges
Table 2: Other Key JP Specific opportunities in Complex Mab biosimilar area
Table 3: Opening Opportunities in Biosimilar Space in Japan
Table 4: Japanese Companies in the Biosimilar Space
Filgrastim biosimilar Japan - Neutropenia Market dynamics, Intensified Competition in Filgrastim Biosimilar Space?
Launch of Pegfilgrastim by KHK in Japan- How will it impact market dynamics for Filgrastim biosimilar?
Dosage Strength: Comparison of each available BS vs. GRAN (Originator) – Does one need the photocopy of a JP originator product to get approval - A Myth?
What type of Bridging study was done by Sandoz for JP approval of its Ex-Japan approved Filgrastim BS?
Dosage strength comparison of Filgrastim BS vs. GRAN BS-
Regulatory studies submitted for “Made in Japan” vs. “ Made for Japan” GRAN BS
Fuji Pharma/Mochida GRAN BS
Sandoz/Sawai GRAN BS
NHI reimbursement pricing – Trends for GRAN biosimilar
% 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
Observed Impact Post two years of Launch in Crowded Filgrastim BS market-
Estimated volume share vs. Gran - Same as the best-selling generic small molecule penetration in Japan….
Impact of “Made & Tested in Japan” vs. “Imported by Japan” on Filgrastim BS market share dynamics post two years of launch
G-Lasta launch and uptake impact on Filgrastim BS market
Table 5: Local vs. Overseas Clinical Studies Submitted for JP approval by each BS player
Table 6: Mochida- Filgrastim BS studies submitted for Approval
Table 7: Nippon Kayaku- Filgrastim BS studies submitted for Approval
Table 8: Sandoz- JP Filgrastim BS – same as US dosage strength- Studies submitted for JP approval
Table 10: FILGRASTIM BS – Competitive landscape – Market strategy of each player
Table 11: Sales Trend of Filgrastim BS/GRAN/G-LASTA
Chart 1: Japan Neutropenia Market dynamics- Change in last one year
Chart 2: Japan Neutropenia Market – Market share of each key player
Chart 3: Volume share trends of GRAN and Filgrastim BS
Findings from JP approval of First complex mAb - Remicade biosimilar 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 to Remicade biosimilar-
Role of JP clinical studies
Originator NHI Price cut in Next NHI price revision (April-2016)
Table 12: Clinical development of Remicade biosimilar – Clinical studies data submitted for JP approval
REMICADE BIOSIMILAR JAPAN MARKET DYNAMICS- Role of PhIII study in respective indications- Only RA study carried out
Remicade use in hospitals
Remicade use in DPC hospitals
Remicade biosimilar use may reduce working capital of hospitals to some extent
Co-pay needed for Remicade treatment in Japan- High cost healthcare reimbursement benefit has a key role to play- Reforms under discussion-April-2016 price revision may change current co-pay benefit dynamics
Competitive landscape of Remicade biosimilar-
Nippon Kayaku’s entry in RA market
Nichi-Iko’s late entry
Table 13: Clinical Data Comparison of CT-P13 vs. INX in RA
Early uptake of LLY BS ENCOURAGING- FUJIFILM LANTUS BS- The first Insulin “Made in Japan” on the way…
Regulatory studies submitted for Lantus BS approval in Japan- Only one Ph 3 study included JP patients, else all studies on Foreign patients submitted for approval.
NHI reimbursement pricing of Lantus BS in Japan
Early uptake encouraging and better than EU- Probable reasons??
Competitive Landscape in Japan
Change in Market dynamics of Lantus in Japan- DPC use of Lantus.
Table 14: Lantus, Lantus XR and Insulin Glargine “BS”- Dosage Strength/NHI Price
Table 15: Lantus BS Estimated Volume share in Japan/EU market post Launch
Table 16: Clinical studies submitted for Lantus BS approval in Japan
Table 17: Other Key Biosimilar Opportunities in Insulin area in Japan
Launched biosimilar in Japan- Uptake Varies per Therapy area
Growth Hormone - Erythropoietin (EPO) - Uptake vs. which opportunity poised best for highest penetration?
EPO- Do market forces allow this biosimilar market to grow like EU??
Japan – Anemia market Dynamics- Trend of market share of key EPO in 2014
Table 18: Launched biosimilar in Japan- Uptake Varies per Therapy Area
Table 19: Anemia Market- Market share and sales of Erythropoietin
Table 20: Niche opportunities other than complex mAb
Chart 4: Japan Anemia market- Trends of Market share of each player
Chart 5: Japan Anemia market – 12 month cumulative market share
AUTOIMMUNE AND ONCOLOGY BIOSIMILARS: JP Specific Opportunity other than key complex MAB
AUTOIMMUNE BIOSIMILARS: RA Market – Share of KEY RA mAb DIFFER in Japan vs. WW Market
Enbrel BS – Next opportunity in RA space after Remicade
Humira -a limited no of players in Japan? - Probable Reasons
Actemra and Cimzia- Opportunities beyond 2020 and more attractive?
Patent expiry (Indication wise JP patents, Reexamination period expiry) and Competitive Landscape of Autoimmune biosimilar in Japan- Market dynamics will be different for Remicade/Humira/Enbrel biosimilar despite targeting similar key markets
Table 21: RA Biologics sales Trend Japan 2010-2014
Chart 6: RA biologics Market share
ONCOLOGY BIOSIMILAR IN JAPAN - HERCEPTIN followed by AVASTIN will be the first in the market
Herceptin Biosimilar- CLEOPATRA success and MARINE failure makes it an interesting opportunity- A Next mAb opportunity to watch out for in Japan
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- Era starts with Expected launch of Herceptin biosimilar in 2016/2017in Japan
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
Japan biosimilar Regulatory Guidelines: Key Take away
JP Requirement: Reference Product, Interchangeability/Substitution, Pharmacovigilance
JP Requirement: PMS for Biosimilar
Somatropin BS
Epoetin Alfa BS
Label for biosimilar in Japan
Annexure-3: Biosimilar Guidelines Adopted By Various Countries
Current Status of pipeline of Each Active Company in BS space:
What is in and what is left?
Some are still in a dilemma whether to enter?
Most of the companies have cherry picked couple of biologics from a full basket
In place for most of the JP Innovator + GE companies- Local GE companies still under dilemma of entering….
JP specific hurdles and drivers-
Govt. measures to increase use of generics comes under high cost medical care benefit system- What to expect in next scheduled NHI price revision???
DPC hospitals- Changing scenario
Table 27: Co-pay Slabs in Japan
Table 28: Revised Pricing of key biologics in Japan
JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners. Now thrives in Regenerative Medicine (Table 29,30)
Meiji Seika Pharma (MSP) – Trastuzumab Race- May not be the first one (Table 31)
Fuji Film - Kyowa Kirin Biologics (FF-KKH) - Looking beyond Domestic Opportunities, First step in that direction by FKB238 JV with Astrazeneca (Table 32)
Nichi-Iko - Aspiring to Capture Overseas Markets As Well, Plans to file Remicade BS in US in 2018 (Table 33)
Mochida: Now Equipped with Full Basket for Being a Top Biosimilar Player in Japan (Table 34)
Nipro Pharma: Not Much Development Following First Success
Yoshindo: A ‘Three Step’ Approach to Build a ‘Bio Company’
Nippon Kayaku - Pioneering ‘New Age’ Of Biosimilars by First launching Remicade BS in Japan- A slow start but situation will change soon (Table 35)
Mitsubishi Tanabe: Late Entrant But With Many Strengths
Sawai: Intends to Establish Sales team in Biosimilar Field in next few years
Towa: May Venture in the Biosimilar Space in near term
Daiichi Sankyo - Premium Generics Business. Will Prioritize Biosimilars- Ph III for Enbrel BS started in 2014
UMN Pharma - Transforming Vaccines Heritage into New Generation Biologics but No major progress in recent past
Kissei: Focus to be a Niche Player in BS space
Kyowa Hakko Kirin: Gearing up for Bigger Pie- AZN JV is the first step
Aska Pharmaceuticals - Barriers to Gain from Partner’s Pipeline
Toyobo Biologics - Eying Biosimilars CMO Business
Gene Techno Science- JP Rising star in biosimilar and biobetter space (Table 36)
Fuji Pharma- Dynamic Specialty Pharma Focusing on Biosimilars
Itochu Chemical Frontier- A trading house with New role in Biosimilar value chain
MGC Pharma- A Bio-pharmaceutical CMO
Annexure-1: Active companies in biosimilar Space in Japan -Domestic JP Cos, Foreign Companies in Japan
Annexure-2: Year wise Partnership in Biosimilar Space in Japan
Annexure-3: Biosimilar Guidelines Adopted by Various Countries

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