Filgrastim BS and Lantus BS Approval- Encouraging uptake and a lesson to fast track JP approval based on Ex-Japan data! Remicade biosimilar “NK” – A slow start does not pull back NK in starting PhIII for Herceptin BS in Japan Active companies in Biosimilar Space: Local Japanese Generic Giants- Opening the door for Biosimilars in Japan? – Will go for All or Niche in BS space???- Opportunities beyond 2020?

Encouraging Uptake of Filgrastim BS and Lantus BS in 2015 in Japan is indicative of Japan being a key important market after the EU for growth of Biosimilar players in the next five years. Less stringent regulatory environment vs. US for approval, increasing healthcare burden and strong foothold of the marketers have played key roles in this early uptake which is at par to one of the best generic small molecule penetration in Japan in a short time (Filgrastim BS-volume share~45% in two years, Lantus BS- ~9% in 2 months vs. Lipitor generics ~50% volume share).

In contrast, there is a very slow uptake of Remicade Biosimilar post one year launch (~1% volume share). Biosimilars remains to be the key weapon to curb increasing healthcare cost in Japan & there is a forward pressure on Chuikyo (Central social Insurance Medical Council) 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 coming times 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 PhIII study involved 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. US for BS approval.

Biosimilar of Complex mAb structure is an opportunity of cumulative market size of ¥300b in the next three years in Japan. It will open doors for first oncology biosimilar mAb in Japan after Remicade BS launch in 2014, while in next 7 years it is cumulative ¥600b market opportunity for biosimilar players.

While analyzing the launched biosimilar penetration since 2009 launch in Japan (Growth hormone, Erythropoietin, G-CSF), 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 decide uptake timeline and penetration of each biosimilar in Japan.

Since 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 ride on their back of 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 biosimilar space as per their specialty therapy area- like ophthalmology BS (Lucentis), Enzyme therapy BS (JCR)

In this report, we attempt to analyze trend/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 detail BS market of EPO, Filgrastim/Pegfilgrastim/ Insulin/Lantus apart from other key complex Mab Biosimilar opportunities and list out niche opportunities in biosimilar space in Japan. It details all major consolidation activities done by JP/Foreign companies in biosimilar space in the last five years and crisp summary on strategies of each key player (~21 JP local companies, multinational companies), their interest & focus for future collaboration in biosimilar space.