Lewes, DE -- (SBWIRE) -- 03/30/2016 -- 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.

EXECUTIVE SUMMARY

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

LAUNCHED BIOSIMILARS IN JAPAN:

FILGRASTIM (GRAN) BS:

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?

INSIGHT FROM THE CLINICAL STUDIES SUBMITTED FOR REGULATORY APPROVAL OF GRAN BS

Dosage strength comparison of Filgrastim BS vs. GRAN BS-

Regulatory studies submitted for "Made in Japan" vs. " Made for Japan" GRAN BS

- Teva/NK's 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 9: NHI REIMBURSEMENT pricing trend of GRAN, FILGRASTM BS and G-LASTA
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

REMICADE BIOSIMILAR:

SLOW UPTAKE POST ONE YEAR IN MARKET BUT SWITCH DATA AND EXPECTED GOVERNMENT INCENTIVES FOR BS USE WILL CHANGE PICTURE IN NEXT TWO-THREE YEARS

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

LANTUS BIOSIMILAR- JAPAN PERSPECTIVE

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

LESSONS FROM OTHER LAUNCHED BIOGENERICS PROGRESS IN JAPAN SINCE 2009 & OTHER POTENTIAL NICHE BS OPPORTUNITIES

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

OTHER NICHE OPPORTUNITIES IN AUTOIMMUNE THERAPY AREA

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

REGULATORY APPROVAL REQUIREMENT FOR COMPLEX MAB BIOSIMILAR IN JAPAN
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

Annexure-3: Biosimilar Guidelines Adopted By Various Countries

LICENSING/CONSOLIDATION ACTIVITIES IN BIOSIMILAR SPACE IN JAPAN-
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

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 Countrie

For more information Visit at: http://www.marketresearchreports.com/mp-advisors/japan-biosimilar-active-players-quest-specialty-niche-bs-space

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