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
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