New Phase of Mab Biosimilar Knocks the Door for Biosimilar Opportunities In Japan

MUMBAI, January 21, 2015 /PRNewswire/ --

The launch of Remicade biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than U.S. in adapting to biosimilar use. After nine years of continuous efforts by the JP government to promote increased use of generics (started in 2006 by launching various benefits for GE use at Pharmacy, hospital level) - now in 2014, Generic penetration of small molecules is changing the trend line and moving towards faster market penetration. While for biosimilars since their launch from 2009- various Japan specific factors has played role for each of them varied market penetration (Growth hormone, Erythropoietin, G-CSF).

2015 will be a litmus test for the next five years cumulative ¥400b biosimilar opportunity in Japan and will give clarity on the importance of "Made in Japan" (Filgrastim biosimilar competition amongst six players) and "Tested by Japan" (NK's Remicade biosimilar) factor for biosimilar penetration. It remains to be seen whether Japan will repeat the story of EU uptake (likes of Norway) for Remicade biosimilar or will follow any of the JP trend line of launched biosimilar (Growth hormone, Erythropoietin, G-CSF launched since 2009) for market penetration.

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Approval of Remicade biosimilar with broader label (RA,UC,CD-PMS required for UC/CD) based on PhIII data of EU/Korean RA (Rheumatoid Arthritis) patients and PhI/IIb data in JP patients depict Japanese regulators to be less stringent than US and more or less similar to EU regulators for biosimilar approval requirements and provides ease on regulatory front for entering in Japan biosimilar market.

Consolidation activities are in place for biosimilar entry by a couple of big players (Daiichi-Sankyo, KHK), JP Innovator+ GE companies (Meiji, Fujifilm, Nippon Kayaku, Mochida, and Kissei), Global Multinationals (Pfizer, Sandoz) and some rising star JP local companies (Yoshindo, Gene Techno Science, Sanwa Kagaku). Recent learning suggests that expectations from partnering are not met at many places. This report provides a crisp summery on activities and plans of ~19 Japanese companies venturing in bio-similar space and ~6 multi-national companies that are going to play important role in the space. It also highlights how the consolidations activities are rapping up currently in biosimilar space, JP companies interest in hedging risk of biosimilar development by partnering with more than one company and where the opportunities are left unexplored for each RA and Oncology mAb.

In this report, along with JP regulatory/IP landscape for each mAb biosimilar opportunity, we attempt to evaluate the future competitive landscape in Japan, and assess the overall attractiveness of the same for market penetration (JP specific factor/Therapy specific factor). Considering NHI reimbursement bracket for each product, current market size of originator, expected no. of biosimilar players, JP biosimilar local companies key strength in specific therapy area/market (Hospital/GP/DP/DPC) etc.. - We try to identify the key determinates to succeed for each of the biosimilar opportunity in Japan.

Table of Contents 

Executive Summary 

• 2015- A year of litmus test for complex mab biosimilar penetration in Japan??
• Upcoming next five year opportunities in biosimilar space in Japan

Table 1: Summary Table - Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges

Table 2: Opening Opportunities in Biosimilar Space in Japan

Table 3: Japanese Companies in the Biosimilar Space

Table 4: Launched biosimilar in Japan- Uptake Varies per Therapy Area

Table 5: Filgrastim/Gran biosimilar- Competitive landscape- Market strategy of each player

Table 6: NHI Reimbursement Price- Gran Biosimilar Pricing Trend

Table 7: Clinical development of Remicade biosimilar - Clinical studies data submitted for JP approval

Table 8: Clinical Data Comparison of CT-P13 vs. INX in RA

Table 9: Japan IP landscape of Key biosimilars focusing on autoimmune Disease

Table 10: Japan competitive landscape of key biosimilars focusing on autoimmune disease

Table 11: Japan IP landscape of key biosimilars focusing on oncology disease

Table 12: Japan competitive landscape of key biosimilars focusing on oncology disease

Table 13: Co-pay Slabs in Japan

Table 14: Revised Pricing of key biologics in Japan

Table 15: JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners

Table 16: Meiji Seika Pharma (MSP) - Ahead of Peers in Trastuzumab Race

Table 17: Fuji Film Kyowa Kirin Biologics (FF-KKH) - Looking Beyond Domestic Opportunities

Table 18: Nichi-Iko - Aspiring To Capture Overseas Markets As Well

Table 19: Mochida: Revving Up Collaboration Efforts

Table 20: Nippon Kayaku - Pioneering 'New Age' Of Biosimilars

Annexure 

1. Active companies in biosimilar Space in Japan -Domestic JP Cos, Foreign Companies in Japan
2. Year wise Partnership in Biosimilar Space in Japan
3. Biosimilar Guidelines Adopted By Various Countries

Tables: 

1. Summary Table - Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges
2. Opening Opportunities in Biosimilar Space in Japan
3. Japanese Companies in the Biosimilar Space
4. Launched biosimilar in Japan- Uptake Varies per Therapy Area
5. Filgrastim/Gran biosimilar- Competitive landscape- Market strategy of each player
6. NHI Reimbursement Price- Gran Biosimilar Pricing Trend
7. Clinical development of Remicade biosimilar - Clinical studies data submitted for JP approval
8. Clinical Data Comparison of CT-P13 vs. INX in RA
9. Japan IP landscape of Key biosimilars focusing on autoimmune Disease
10. Japan competitive landscape of key biosimilars focusing on autoimmune disease
11. Japan IP landscape of key biosimilars focusing on oncology disease
12. Japan competitive landscape of key biosimilars focusing on oncology disease
13. Co-pay Slabs in Japan
14. Revised Pricing of key biologics in Japan

Annexure 

1. Active companies in biosimilar Space in Japan -Domestic JP Cos, Foreign Companies in Japan
2. Year wise Partnership in Biosimilar Space in Japan
3. Biosimilar Guidelines Adopted By Various Countries

Charts: 

1. Launched biosimilar in Japan- Volume Market Share trend up to 2014
2. Japan Anemia Market dynamics- Trend of Market share in 2014
3. Japan Anemia Market dynamics- 12 month Cumulative market share
4. Japan Neutropenia Market dynamics - 12 month cumulative Market share
5. Japan Neutropenia Market dynamics- Volume share trends of Gran and Generics

Companies Covered: 

• Chugai
• Kyowa Hakko Kirin
• Toray
• Kissei
• JCR
• Abbott JP
• Mitsubishi Tanabe
• Takeda
• Zenyaku Kogyo
• Eisai
• Aska
• Daiichi Sankyo
• Fuji Pharma
• Fujifilm Pharma
• JCR
• Meiji Seika Pharma
• Mochida
• Nichi-Iko
• Nippon Kayaku
• Nipro Pharma
• Sawai
• Towa
• Taiyo
• Toyobo biologics
• UMN Pharma
• Yoshindo
• Gene Techno Science
• Sandoz Japan K K
• Symphogen A/S
• Dong-A
• LG lifesceinces
• Celtrion
• Daiichi Sankyo Espha
• Catalent Pharma Solution
• UNIGEN

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