Avik Das | TNN | Mar 28, 2016, 02.52 PM IST
BENGALURU: Biopharmaceutical company Biocon said it got approval from Japan’s health ministry to sell its biosimilar Insulin Glargine in the country.
The product, which is a ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine, is expected to be launched in Japan in the first quarter of 2017 with its commercial partner FUJIFILM Pharma Co. Ltd, Biocon said on Monday.
The move will help Biocon capture a significant share of the Japanese Glargine market, which is about $144 million and second largest market outside of North America & Europe.
“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,” chairperson and managing director Kiran Mazumdar-Shaw said.
Biosimilars are biologic products, made inside living cells and has no clinical differences in terms of safety and effectiveness from the main product. They are however not considered duplicates, like generics, by regulators as it is impossible to manufacture exact copies of biotech drugs.
|Traded as||BSE: 532523
|Headquarters||Bangalore, Karnataka, India|
|Kiran Mazumdar-Shaw, (Chairman & MD)|
|Revenue||₹22.41 billion (US$330 million) (2014–15)|
|₹3.61 billion (US$54 million) (2014–15)|
Number of employees
|5,585 (Mar 2011)|
//////Biocon, Insulin Glargine, approval, Japan