India's Biocon gains Japanese approval for insulin glargine

Indian drugmaker Biocon (BSE: 532523) says that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved its biosimilar insulin glargine. The company through its commercial partner, Fujifilm Pharma (FFP) will now offer high quality, yet affordable, world class products to diabetes patients in Japan, it says.

The product is a ready-to-use, prefilled disposable pen with 3ml of 100IU insulin glargine, expected to be launched in the first quarter of fiscal year 2017, aiming to capture a significant share of the Japanese glargine market of worth around $144 million, which is the second largest market outside of North America and Europe and is largely dominated by disposable pens. Insulin glargine is the active ingredient in French pharma major Sanofi’s (Euronext: SAN) blockbuster drug Lantus.

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 1 diabetes patients by its 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.

Biocon is recognized as Asia’s largest insulins producer and has been committed to affordable diabetes management through rh-insulin (Insugen) and insulin glargine (Basalog) in India and several emerging markets. The company currently 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.