No Marshmallows, Just Term Papers
April 08th 2016 Mumbai, India: Bharatbook.com announces a report on “ Japan Bio similar - Active Players In Quest of a Specialty & Niche BS space ”. Abenomics measures and government involvement in bio similar use would lead to the same type of progress for complex mAb Bio similars in the coming times in Japan.
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 Bio similar 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 https://www.bharatbook.com/healthcare-market-research-reports-741640/japan-biosimilar-active-players-quest-specialty-niche-bs-space.html (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 Bio similar post one year launch (~1% volume share). Bio similars 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 bio similars. We see that Abenomics measures and government involvement in bio similar use would lead to the same type of progress for complex mAb Bio similars 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 bio similar in 2014/2015 in the Japan pharma market demonstrated more flexibility for EU- Ex-Japan data by JP regulatory authorities for a bio similar approval and a less stringent path vs. US for...