The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved the sale of Glargine, a significant achievement for Biocon and its commercial partner, Fujifilm Pharma, the biotech major said in a filing to BSE.

 

"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," Biocon Chairperson and MD Kiran Mazumdar-Shaw said.

 

The company hopes to enable the Japanese government to bring down its healthcare expenditure on diabetes with the use of this cost effective, high quality biosimilar Insulin Glargine, she added.

 

Biocons product is a ready-to-use prefilled disposable pen with 3 ml of 100IU Insulin Glargine and is expected to be launched in first quarter of next fiscal, the company said.

 

The company aims to capture a significant share of the Japanese Glargine market of USD 144 million which is the second largest market outside of North America and Europe and is largely dominated by disposable pens, it added.

 

The approval has been obtained post local Phase III clinical studies in over 250 Type 1 diabetes patients by its partner in Japan.

 

The company 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.