Therapeutic Class Overview: Emergence of Biogenerics Era in Japan - it's time to welcome Antibody Biosimilars of Foreign Origins Soon
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
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: Intensied 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
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: Intensied 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
