Biosimilar Players Seek Specialty & Niche Space In Japan

Encouraging uptake of Filgrastim and Lantus biosimilars (BS) in 2015 in Japan is indicative of Japan being a key market after the EU for growth of biosimilar players in the next five years. Less stringent regulatory environment compared to the U.S. for approval, increasing healthcare burdens, and strong marketer footholds have played key roles in this early uptake, which is comparable to the best generic small molecule penetration in Japan in a short time (Filgrastim BS-volume share~45 percent in two years, Lantus BS- ~9 percent in 2 months vs. Lipitor generics ~50 percent volume share).

In contrast, there is a very slow uptake of Remicade biosimilar post one year launch (~1 percent volume share). Biosimilars are poised to curb increasing healthcare cost in Japan, and the Chuikyo (Central Social Insurance Medical Council) is being pressured by Zaimu-sho (Ministry of Finance- Japan) to increase use of biosimilars. We see that Abenomics measures and government involvement in biosimilar use would lead to the same type of progress for complex mAb biosimilars in the future in Japan

The launch of Sandoz EU approved dosage form of Filgrastim BS in Japan, and Lantus BS based mainly on foreign studies (only one Ph. 3 study involved Japanese (JP) patients from the eight studies submitted for approval) along with Celltrion-NK Remicade biosimilar in 2014/2015 in the Japan pharma market demonstrated more flexibility for EU- Ex-Japan data by JP regulatory authorities for a biosimilar approval and a less stringent path vs. U.S. for biosimilar approval.

Complex mAb biosimilars promise a cumulative market size of ¥300b in the next three years in Japan. It will open doors for the first oncology biosimilar mAb in Japan after the Remicade BS launch in 2014. In the next 7 years, mAbs are forecasted to be a cumulative ¥600b market opportunity for biosimilar players.

While analyzing the launched biosimilar penetration since the entrance of Growth hormone, Erythropoietin, G-CSF in 2009 in Japan, use of the product in DPC hospitals, simple protein moiety, and product reimbursement under high cost medical care benefit programme of NHI/JP government are the key JP specific factors which determine uptake timeline and penetration of each biosimilar in Japan.

Over the last five years, most of the companies have some alliance in place for biosimilars, with most of the Japanese companies undertaking pacts with South Korean companies to garner their biosimilar mAb expertise. There is a trend of doing product specific alliance by most of the JP companies active in BS space and to go step by step on this high risk/high return opportunities. Overall, in the Japan market, each opportunity has a different competitive landscape for itself, and some companies are looking for niche opportunities in the biosimilar space as per their specialty therapy area- like ophthalmology BS (Lucentis) and Enzyme therapy BS (JCR)

In this report, we attempt to analyze trends/requirement of regulatory approval of biosimilars based on Ex-Japan clinical trial data, Factors responsible for each key launched biosimilar penetration ("Made in Japan" vs. "Tested by Japan"), and the future competitive landscape in the biosimilars space in Japan. We also attempt to analyze the BS market of EPO, Filgrastim/Pegfilgrastim/ Insulin/Lantus apart from other key complex Mab Biosimilar opportunities and list out niche opportunities in the biosimilar space in Japan. It details all major consolidation activities done by JP/Foreign companies in the biosimilar space in the last five years and brief summaries on strategies of each key player (~21 JP local companies, multinational companies) and their interests & focuses for future collaboration in the biosimilar space.

Complete Report Details @ https://www.wiseguyreports.com/reports/273867-japan-biosimilar-active-players-in-quest-of-a-specialty-niche-bs-space

Table Of Contents – Major Key Points

- Biosimilars (BS) – One of the key weapons for Government to curb healthcare cost in Japan
- Uptake of Filgrastim and Lantus BS in Japan - Better than Small molecule generics—Key reasons
- A slow start of Remicade BS "NK"- Will it change in near term or take time
"Abenomics" initiatives to Promote BS use- How will it change the current scenario
BS use must to curb healthcare cost- A forward Pressure on "Chukiyo"- Japan early than US in approving "mAb" biosimilar- at What Price
- Upcoming next opportunities in biosimilar space in Japan beyond key Onco/RA drugs and Post 2020…
- Licensing activities in biosimilar space in Japan-
Current Status of pipeline of Each Active company in the BS space:
What is in and what is left
Are some still in the dilemma of entering the BS space
Most of the companies have cherry picked couple of biologics from the full basket
- Launch timeline and Our view on Each potential key opportunity in Biosimilar space in Japan based on
Regulatory/Development investment - JP dosage strength of originator vs. US dosage strength of Originator
JP Market size and Reimbursement/NHI Price of Originator
Expected no. of players in the biosimilar space in Japan, Innovator strategy in Japan, Re-examination period expiry
Key challenges for each biosimilar opportunity in Japan
- Niche BS opportunities in Japan
- Factors driving biosimilar penetration in Japan – Government incentives to prescribe "BS" is key.
JP specific factor-
Use in DPC hospitals
- Reimbursement under high cost medical care Government benefit programme.
Price difference for small molecule generic use vs. biologic - how big role it will play for biosimilar penetration
Therapy Specific Factor-
Acute vs. Chronic/ Pediatric vs. Adult
Support therapy vs. treatment therapy
Physician experience of using class of therapy drugs…

Table 1: Summary Table –Originator JP Dosage strengt, Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges
Table 2: Other Key JP Specific opportunities in Complex Mab biosimilar area
Table 3: Opening Opportunities in Biosimilar Space in Japan
Table 4: Japanese Companies in the Biosimilar Space

LAUNCHED BIOSIMILARS IN JAPAN:

FILGRASTIM (GRAN) BS:

• Filgrastim biosimilar Japan - Neutropenia Market dynamics, Intensified Competition in Filgrastim Biosimilar Space
• Launch of Pegfilgrastim by KHK in Japan- How will it impact market dynamics for Filgrastim biosimilar
• Dosage Strength: Comparison of each available BS vs. GRAN (Originator) – Does one need the photocopy of a JP originator product to get approval - A Myth
• What type of Bridging study was done by Sandoz for JP approval of its Ex-Japan approved Filgrastim BS

INSIGHT FROM THE CLINICAL STUDIES SUBMITTED FOR REGULATORY APPROVAL OF GRAN BS

• Dosage strength comparison of Filgrastim BS vs. GRAN BS-
• Regulatory studies submitted for "Made in Japan" vs. " Made for Japan" GRAN BS
• Teva/NK's GRAN BS
• Fuji Pharma/Mochida GRAN BS
• Sandoz/Sawai GRAN BS

NHI reimbursement pricing – Trends for GRAN biosimilar

• % price cut to Originator- Impact on NHI reimbursement price to biosimilar
• For Sandoz, Late entry did not result in any NHI reimbursement price disadvantage-Implications

Observed Impact Post two years of Launch in Crowded Filgrastim BS market-

• Estimated volume share vs. Gran - Same as the best-selling generic small molecule penetration in Japan….
• Impact of "Made & Tested in Japan" vs. "Imported by Japan" on Filgrastim BS market share dynamics post two years of launch
• G-Lasta launch and uptake impact on Filgrastim BS market

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