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

  • ID: 2763281
  • Report
  • February 2014
  • Region: Japan
  • 31 Pages
  • MP Advisors
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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 it includes 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 the authors 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, the authors 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, the authors do not arrive at any investment recommendations from the sector
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- 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


- 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 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


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



- 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
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