Biocon’s Insulin Glargine Gets JAPAN FDA Approval
Bangalore-based pharma major Biocon Ltd. (BSE code: 532523, NSE: BIOCON) has received the approval of Japan’s approved for its biosimilar Insulin Glargine, which was developed in commercil partnership with FUJIFILM Pharma Co. Ltd (FFP) to provide an affordable, world class product to diabetes patients in Japan.
The product is a ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine, to be launched in Q1 FY2017, aiming to capture a significant share of the Japanese Glargine market of US$ 144 Million, which is the second largest market outside of North America & Europe and is largely dominated by disposable pens.
The approval for Insulin Glargine has been obtained post successful completion of initial development by Biocon and local Phase III Clinical Studies in over 250 Type 1 Diabetes patients by our partner in Japan. Biocon’s manufacturing facilities for Insulin Glargine, and its state-of-the-art disposable pen assembly facility, were inspected and approved by the Japanese regulatory authorities. This pen assembly facility was inaugurated in September 2015 for the launch of Biocon’s Insulin Glargine pen branded as ‘Basalog One’ in India.
Biocon Chairperson & MD Kiran Mazumdar-Shaw said: “The Insulin Glargine approval in the highly regulated market like Japan, marks a huge credibility milestone for Biocon. We see this as a significant achievement in our journey of making global impact in diabetes management through our affordable biosimilar insulins. We hope to enable the Japanese government to bring down its healthcare expenditure on diabetes with the use of this."
This approval will enable Biocon to cater the needs of 7.2 million diabetes patients in Japan. Biocon is Asia’s largest insulins producer and sells brands such as rh-Insulin (Insugen) and Insulin Glargine (Basalog) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh-Insulin and in over 20 countries for Insulin Glargine.
It is also developing Insulin Glargine for the developed markets outside of Japan in collaboration with Mylan.[tags, biocon, japan market, approval, insulin glargine, injectible insulin, fujifilm pharma company, japan pharmaceuticals,basalog one]