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  4. > New Phase of Mab biosimilar knocks the door Biosimilar Oppurtunities In Japan

The launch of Remicade biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than U.S. in adapting to biosimilar use. After nine years of continuous efforts by the JP government to promote increased use of generics (started in 2006 by launching various benefits for GE use at Pharmacy, hospital level) – now in 2014, Generic penetration of small molecules is changing the trend line and moving towards faster market penetration. While for biosimilars since their launch from 2009- various Japan specific factors has played role for each of them varied market penetration (Growth hormone, Erythropoietin, G-CSF).

2015 will be a litmus test for the next five years cumulative ¥400b biosimilar opportunity in Japan and will give clarity on the importance of “Made in Japan” (Filgrastim biosimilar competition amongst six players) and “Tested by Japan” (NK’s Remicade biosimilar) factor for biosimilar penetration. It remains to be seen whether Japan will repeat the story of EU uptake (likes of Norway) for Remicade biosimilar or will follow any of the JP trend line of launched biosimilar (Growth hormone, Erythropoietin, G-CSF launched since 2009) for market penetration.

Approval of Remicade biosimilar with broader label (RA,UC,CD-PMS required for UC/CD) based on PhIII data of EU/Korean RA (Rheumatoid Arthritis) patients and PhI/IIb data in JP patients depict Japanese regulators to be less stringent than US and more or less similar to EU regulators for biosimilar approval requirements and provides ease on regulatory front for entering in Japan biosimilar market.

Consolidation activities are in place for biosimilar entry by a couple of big players (Daiichi-Sankyo, KHK), JP Innovator+ GE companies (Meiji, Fujifilm, Nippon Kayaku, Mochida, and Kissei), Global Multinationals (Pfizer, Sandoz) and some rising star JP local companies (Yoshindo, Gene Techno Science, Sanwa Kagaku). Recent learning suggests that expectations from partnering are not met at many places. This report provides a crisp summery on activities and plans of ~19 Japanese companies venturing in bio-similar space and ~6 multi-national companies that are going to play important role in the space. It also highlights how the consolidations activities are rapping up currently in biosimilar space, JP companies interest in hedging risk of biosimilar development by partnering with more than one company and where the opportunities are left unexplored for each RA and Oncology mAb.

Table Of Contents

New Phase of Mab biosimilar knocks the door Biosimilar Oppurtunities In Japan
- 2015- A year of litmus test for complex mab biosimilar penetration in Japan??
- Upcoming next five year opportunities in biosimilar space in Japan
- Factors driving biosimilar penetration in Japan - What will weigh more? - JP specific factor or Therapy specific factor or else???
o JP specific factor-
- Use in DPC hospitals
- Price difference for small molecule generic use vs. biologic- how big role it will play for biosimilar penetration
- Reimbursement under high cost medical care Government benefit programme
o Therapy Specific Factor-
- Acute vs. Chronic/ Pediatric vs. Adult
- Support therapy vs. treatment therapy
- Physician experience of using class of therapy drugs….
- Consolidation activities in biosimilar space in Japan-
o Alliance done by JP innovator, JP Innovator+ Generic, JP generic companies -
- Most of companies have cherry picked couple of biologics from full basket
- Some are still in dilemma for entering
- Launch timeline and Our view on Each potential key opportunity in Biosimilar space in Japan based on
o JP Market size, 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

Table 1: Summary Table - Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges
Table 2: Opening Opportunities in Biosimilar Space in Japan
Table 3: Japanese Companies in the Biosimilar Space

- Launched biosimilar in Japan- Uptake Varies per Therapy area
- Growth Hormone, Erythropoietin, Filgrastim- Uptake vs. which opportunity poised best for highest penetration?
o EPO- Do market forces allow this biosimilar market to grow like EU??
o Japan - Anemia market Dynamics- Trend of market share of key EPO in 2014
- Filgrastim biosimilar- Japan- Neutropenia Market dynamics, Intensified Competition In Filgrastim Biosimilar Space?
- Launch of Pegfilgrastim by KHK in Japan- How it will impact market dynamics for Filgrastim biosimilar?
o 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
Table 4: Launched biosimilar in Japan- Uptake Varies per Therapy Area
Table 5: Filgrastim/Gran biosimilar- Competitive landscape- Market strategy of each player
Table 6: NHI Reimbursement Price- Gran Biosimilar Pricing Trend

- Japan biosimilar Regulatory Guidelines: Key Take away
- JP Requirement: Reference Product, Interchangeability/Substitution, Pharmacovigilance
- JP Requirement: PMS for Biosimilar
- Somatropin BS
- Epoetin Alfa BS
- Filgrastim
- Remicade
- Label for biosimilar in Japan
- Findings from JP approval of First complex mAb - Remicade biosimilar in Japan
o Extrapolation of Indication expansion- possible or not? What studies needed/submitted?
o Details of clinical studies submitted for Remicade biosimilar “NK” approval
- NHI reimbursement price to Remicade biosimilar-
o Role of JP clinical studies
o What to forsee for the next two biosimilars expected to get an approval in 2016?
Table 7: Clinical development of Remicade biosimilar - Clinical studies data submitted for JP approval

REMICADE (INFLIXIMAB) BIOSIMILAR - JAPAN MARKET DYNAMICS- For volume market share- Does it repeat the story of Norway? Or market penetration like Epoetin/Filgrastim biosimilar in Japan??? Various factors to account….
- 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
- Co-pay needed for Remicade treatment in Japan- High cost healthcare reimbursement benefit has a key role to play- Reforms under discussion- Oct-2015/April-2016 price revision may change current co-pay benefit dynamics
- Originator NHI Price cut in Next NHI price revision (Oct-2015/April-2016)
- Competitive landscape of Remicade biosimilar-
o Nippon Kayaku's entery in RA market
o Nichi-Iko's late entery
Table 8: Clinical Data Comparison of CT-P13 vs. INX in RA

- Innovator's strategy for improving standard of care in respective therapy area
o Prescribers experience of handling Autoimmune class of Mabs vs. Oncology
- 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
- 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 9: Japan IP landscape of Key biosimilars focusing on autoimmune Disease
Table 10: Japan competitive landscape of key biosimilars focusing on autoimmune disease
Table 11: Japan IP landscape of key biosimilars focusing on oncology disease
Table 12: Japan competitive landscape of key biosimilars focusing on oncology disease

CONSOLIDATION ACTIVITIES IN BIOSIMILAR SPACE IN JAPAN- In place for most of the JP Innovator + GE companies- Local GE companies still under dilemma for entering….
- JP specific hurdles and drivers-
o Govt. measures to increase use of generics comes under high cost medical care benefit system- What to expect in next scheduled NHI price revision???
o DPC hospitals- Changing scenario
Table 13: Co-pay Slabs in Japan
Table 14: Revised Pricing of key biologics in Japan

JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners (Table 15)
Meiji Seika Pharma (MSP) - Ahead of Peers in Trastuzumab Race (Table16)
Fuji Film Kyowa Kirin Biologics (FF-KKH) - Looking Beyond Domestic Opportunities (Table 17)
Nichi-Iko - Aspiring To Capture Overseas Markets As Well (Table 18)
Mochida: Revving Up Collaboration Efforts (Table 19)
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 (Table 20)
Mitsubishi Tanabe: Late Entrant But With Many Strengths
Sawai: 2015 will serve as litmus for full fledge entery in biosimilar
Towa: May Venture the Space by 2016
Daiichi Sankyo - Premium Generics Business Will Prioritize Biosimilars- Enbrel biosimilar is the first go
UMN Pharma - Transforming Vaccines Heritage into New Generation Biologics
Kissei: Intensified Efforts to Build EPO Franchise
Kyowa Hakko Kirin: Gearing up for Bigger Pie
Aska Pharmaceuticals - Barriers to Gain from Partner's Pipeline
Toyobo Biologics - Eying At Biosimilars CMO Business
Gene Techno Science- JP Rising star in biosimilar and biobetter space

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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