DUBLIN, Apr. 21, 2015 /PRNewswire/ --Research and
Markets
(http://www.researchandmarkets.com/research/lz6rz2/new_phase_of_mab)
has announced the addition of the "New Phase of Mab Biosimilar
Knocks the Door - Biosimilar Opportunities In Japan" report to
their offering.
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.
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.
Companies Mentioned
- Aska Pharma
- Daiichi Sankyo
- Fuji Film Kyowa Kirin Biologics
- Gene Techno Science
- JCR Pharma
- Kissei
- Kyowa Hakko Kirin
- Meiji Seika
- Mitsubishi Tanabe
- Mochida
- Nichi-Iko
- Nippon Kayaku
- Nipro Pharm
- Sawa
- Towa
- Toyobo Biologics
- UMN Pharma
- Yoshindo
For more information visit
http://www.researchandmarkets.com/research/lz6rz2/new_phase_of_mab
Media Contact: Laura Wood
, +353-1-481-1716, press@researchandmarkets.net