Therapeutic Class Overview : Emergence Of Biogenerics Era In Japan - It's Time to Welcome Antibody Biosimilars of Foreign Origins Soon

Published: February 2014
No. of Pages: 31

With three products and eight players already in market – Japan biosimilar market will enter new phase of biosimilars with first ‘mab’ approval expected in 2014.  This approval (Remicade- FY03/13A sales ¥73.5, infiximab from Nippon Kayaku by YE 14) will be marked as a milestone development because – 1.) it will open antibody biosimilar market in Japan, and 2.) the approval will be based largely from overseas data.

~ ¥200b worth of biologic products is going off patent by 2015 and this value exceeds ~ ¥400b if we include products that will see their patent expiries by 2021 in Japan (Table 1).   There are number of reasons to believe that follow-on-biologics or biosimilars will not replicate the lethargic growth story of generic – preliminary because the much higher cost of biologic therapy brings significant burden on patients despite relatively low co-pay in Japan – and this will push individuals and DPC Hospitals to use biogeneric products to a greater extent unlike generic drugs.  Secondly, the regulatory supports are going to be stringent enough to ensure quality measures and minimizing the ‘not made in Japan’ factor from prescriber’s and user’s mindsets.

Anticipating this opportunity and favorable macro forces as compared to generics, a number of companies aim to exploit this – Japan has seen a flood like consolidation and partnering activities in biosimilar space (Table 2, Annexure I).  While a dozen+ companies have already laid their road map for biosimilars space, at this time we see Sandoz, JCR, Meiji Seika Pharma, Fuji Film Kyowa Kirin Biologics, Nippon Kayaku, Nichi Iko, Yoshindo etc. to be amongst the key players in biogenerics business in Japan.

It is also noteworthy that large global player, which currently look silent in Japan.

In this piece, we attempt to evaluate the future competitive landscape  (Table 3) of the Biosimilars space in Japan, assess the overall attractiveness of the same, and try to identify the key determinates to succeed in this space.  At this point, we do not arrive at any investment recommendations from the sector

Therapeutic Class Overview : Emergence Of Biogenerics Era In Japan - It's Time to Welcome Antibody Biosimilars of Foreign Origins Soon

Table of Contents

Investment Thesis
Table 1: Opening Opportunities in Biosimilar Space
Table 2: Japanese Companies in The Biosimilar Space
Table 3: Japan Biosimilar Pipeline- Expected Competition

Evolving Biogeneric Landscape In Japan
Table 4: Launched Biogenerics in Japan
Table 5: Top 10 Small molecules vs. Top 10 biologics in Japan

Intensified Competition In Filgrastim Biosimilar Space

  • Nippon Kayaku/Teva Use Robust Clinical Evidences From Overseas
  • Fuji Pharma/Mochida Positions ‘Made In Japan’ To Capture Market
  • Table 6: Filgrastim: Originator vs. Biosimilar Price
  • Table 7: Filgrastim: Competitive Landscape
  • The Originator Preparing To Bring Long-Acting Version

Remicade (Infliximab) Biosimilar Entry Expected In Cy 2014

  • Remicade use in DPC hospitals
  • Remicade biosimilar expected approval Indications
  • Table 8: Clinical Data Comparison Of CT-P13 Vs. INX in RA
  • Table 9: Pipeline Remicade Biosimilar In Japan
  • Table 10: Saving through Remicade biosimilar to Patients

Japan Specific Hurdles & Drivers
Table 11: Likely launch schedule of select biosimilars

Price Difference and DPC Hospitals Business Are Key Drivers Differentiating

Biosimilars Outlook

  • Table 12: Co-Pay Slabs in Japan
  • Table 13: Savings through Biosimilars
  • Table 14: Pricing of Key Biologics in Japan

Regulatory Guidelines: Key Take away

  • JP Requirement: Reference Product
  • JP Requirement: Interchangeability/Substitution:
  • JP Requirement: Pharmacovigilance:
  • JP Requirement: Pms For Biosimilar
  • Somatropin Bs
  • Epoetin Alfa Bs
  • Filgrastim

Select Japanese Companies Venturing Into Biogenerics Space

  • JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners (Table 15)
  • Meiji Seika Pharma (MSP) - Ahead of Peers on Trastuzumab Race (Table16)
  • Fuji Film Kyowa Kirin Biologics (FF-KKH) - Looking Beyond Domestic Opportunities (Table 17)

1. Nichi-Iko - Aspiring To Go Overseas Markets As Well (Table 18)
2. Mochida: Revving Up Collaboration Efforts (Table 19)
3. Nipro Pharma: Not Much Development Following First Success
4. Yoshindo: A ‘Three Step’ Approach to Build a ‘Bio Company’
5. Nippon Kayaku - Pioneering ‘New Age’ Of Biosimilars (Table 20)
6. Mitsubishi Tanabe: Late Entrant But With Many Strengths
7. Sawai: Wait & Watch’ Strategy Continues
8. Towa: May Venture the Space by 2016
9. Daiichi Sankyo - Premium Generics Business Will Prioritize Biosimilars
10. Umn Pharma - Transforming Vaccines Heritage into New Generation Biologics
11. Kissei: Intensied Efforts to Build EPO Franchise
12. Kyowa Hakko Kirin: Gearing up for Bigger Pie
13. Aska Pharmaceuticals - Barriers To Gain From Partner’s Pipeline
14. Toyobo Biologics - Eying At Biosimilars CMO Business

Annexure-1: Consolidation Activities In Biosimilar Space In Japan
Annexure-2: Biosimilar Guidelines Adopted By Various Countries

List of Tables

Table 1 Opening Opportunities In Biosimilar Space
Table 2 Japanese Companies In The Biosimilar Space
Table 3 Japan Biosimilar Pipeline – Expected Competition
Table 4 Launched Biogenerics In Japan
Table 5 Top 10 Small Molecules Vs. Top 10 Biologics In Japan
Table 6 Filgrastim: Originator Vs. Biosimilar Price
Table 7 Filgrastim: Competitive Landscape
Table 8 Clinical Data Comparison Of Ct-P13 Vs. Inx In Ra
Table 9 Pipeline Remicade Biosimilar In Japan
Table 10 Savings Through Remicde Biosimilars
Table 11 Likely Launch Schedule Of Select Biosimilars
Table 12 Co-Pay Slabs In Japan
Table 13 Savings Through Biosimilars
Table 14 Pricing Of Key Biologics In Japan
Table 15 Jcr: Pipeline
Table 16 Msp: Biogenerics Pipeline
Table 17 Ff-Kkb: Biogenerics Pipeline
Table 18 Nichi- Iko: Biogenerics Pipeline Of Biosimilars
Table 19 Mochida: Biogenerics Pipeline
Table 20 Nippon Kayaku: Biogenerics Status

Published By: MP Advisors
Product Code: MP Advisors20

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