The Japanese Ministry of Health, Labour and Welfare (MHLW) has given Biocon its approval to launch its insulin Glargine.

This approval gives Biocon and its partner FUJIFILM Pharma an opportunity to bring quality and affordable medicines to diabetes patients in Japan.

The product comes in the form of a ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine, expected to be launched in the first quarter of fiscal 2017, the company said in a statement.

This is Biocon’s first biosimilar launch in the Japanese market.

Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: “We see this as a significant achievement in our journey of making global impact in diabetes management through our affordable biosimilar insulins.”

Further, as a part of this deal, FUJIFILM Pharma will commercialise the insulin in Japan. Also, Biocon will get some licensing income from FUJIFILM Pharma and will also get milestone-based royalties, the company executives said.

Industry watchers opine that spiralling healthcare costs in the world's third largest economy, coupled with an aging population putting more stress on healthcare spends are forcing the industry to relook at their cost structures.

“The government is one of the largest healthcare spenders when compared on a per capita basis,” said Arun Chandavarkar, CEO, Biocon in a conference call.

This approval will enable Biocon to address the growing needs of diabetes patients in Japan which reported 7.2 million cases in 2015 or a $144-million market, which currently has competitors like Eli Lilly.

This is the second development in the last ten days for Biocon's insulin business.

Biocon SA, its subsidiary entered into an agreement with Mexico-based Laboratorios PiSA, wherein Biocon will manufacture rh-Insulin, a substance that goes into the insulin, while PiSA will manufacture drug product at its facilities in Mexico, which will be sold in the US.

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