Express Pharma

Biocon’s Insulin Glargine receives regulatory approval in Japan

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The product is ready to be launched in Q1 FY17

Biocon announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved its biosimilar Insulin Glargine. This is a significant achievement for Biocon and its commercial partner, FUJIFILM Pharma Co (FFP) as it endorses the company’s endeavour to bring high quality, yet affordable, world class products to diabetes patients in Japan.

The product is a ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine, expected to be launched in Q1 FY17, aiming to capture a significant share of the Japanese Glargine market of $144 million, which is the second largest market outside of North America and Europe and is largely dominated by disposable pens.

The approval for Insulin Glargine has been obtained post successful completion of initial development by Biocon and local Phase III Clinical Studies in over 250 Type I diabetes patients by our partner in Japan. Biocon’s manufacturing facilities for Insulin Glargine, and its state-of-the-art disposable pen assembly facility, were inspected and approved by the Japanese regulatory authorities. This pen assembly facility was inaugurated in September 2015 for the launch of Biocon’s Insulin Glargine pen branded as ‘Basalog One’ in India.

EP News BureauMumbai

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