Kiran Mazumdar Shaw
Kiran Mazumdar ShawReuters File

Biocon, the India-based biopharmaceutical company, said Monday it has received regulatory approval from Japan's ministry of health, labour and welfare for its biosimilar Insulin Glargine product. Biocon will team up with Japan-based Fujifilm Pharma Co. Ltd (FFP) for supplying Glargine, a prefilled disposable pen with 3 ml 100IU insulin.

"This is a significant achievement for Biocon, as it opens the doors for us in this highly regulated market," an official statement said, adding that the product is expected to be launched in the first quarter of financial year 2017. Biocon said it aims to capture a significant share of Japanese insulin Glargine market worth $144 million, which is the second outside of North America and Europe, and is largely dominated by disposable pens.

"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," Kiran Mazumdar-Shaw, the chairperson and managing director of Biocon, said. "We hope 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."

"The approval for Insulin Glargine was 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," the statement said. It added that Biocon's manufacturing facilities for Insulin Glargine, and its disposable pen assembly facility were also inspected and approved by the Japanese regulatory authorities.

Among the Organisation for Economic Cooperation and Development (OECD) countries, Japan ranks second in terms of per capita spending on pharmaceuticals, which is next only to the U.S. The number of people suffering from diabetes in Japan was 7.2 million in 2015, said the statement.

Biocon had earlier signed a deal with Mexico-based drug company PiSA Farmaceutica March 17 to develop an insulin drug for the U.S. market. Biocon stocks traded at Rs 485, up by 4.5 percent from its previous close, at the Bombay Stock Exchange at 3.38 p.m.