The Japanese Glargine market is estimated to be $144 million, Biocon said. It will make the ready-to-use prefilled disposable pen with Glargine at its unit here.
This would be sold by its partner, Fujifilm Pharma, in Japan by June.
The Japanese entity had conducted local Phase-III clinical trials on over 250 Type-1 diabetes patients. Japanese regulators had visited the facility here, which produces Basalog One, the branded product sold in India, prior to the approval. The pen assembly facility was inaugurated in September 2015.
“The approval in Japan gives us huge credibility to take these products in other developed markets,” said Arun Chandavarkar, chief executive, in a conference call. Biocon plans to now seek approval for the Glargine insulin to sell in the US and Europe, for which it has tied up with Mylan. The latter is conducting clinical trials for the biosimilar product in these regions. “This approval in the highly regulated market of Japan marks a huge credibility milestone...we hope to enable the Japanese government to bring down its health care expenditure on diabetes with the use of this biosimilar,” chairperson and managing director Kiran Mazumdar-Shaw said.
Biocon’s product is the generic version of Lantus, the insulin produced by Sanofi, which owns 90 per cent of the market in Japan.
Pharm.D @ SRIPMS-CBE-TN