Biocon: First Indian Company to Enter Japan Market with Biosimilar Insulin


India’s biopharmaceutical company Biocon’s biosimilar insulin glargine got regulatory approval by the Ministry of Health Labour and Welfare (MHLW) of Japan.

Biocon insulin get japan regulatory approvalBiocon is now eligible to sell its biosimilar product –insulin glargine in Japan which has came as a substantial achievement for the company as well as its commercial partner FUJIFILM RI Pharma Co., Ltd., which played a vital role in delivering high quality yet affordable products to the  diabetes patients of Japan.

Fujifilm Pharma Co Ltd _logoInsulin glargine is a slow releasing, once daily basal insulin analogue helps to keep the blood sugar level of diabetic patients in control. The biocon’s biosimilar insulin glargine is a ready-to-use, prefilled disposable pen with 3ml of 100IU insulin glargine. After the initial development by Biocon, the approval came as a result of the positive data shown in the local Phase III clinical studies carried out by their partner in Japan in about 250 Type 1 diabetes patients.

Insulin glargine long-acting basal insulin analogue

Figure 1. Amino acid arrangement in insulin glargine

Biocon Chairperson & Managing Director Kiran Mazumdar‐Shaw said, “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. 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.”

Japanese regulatory authorities has inspected the Biocon’s manufacturing facilities for insulin glargine and its disposable pen assembly facility. In September 2015, the pen assembly facility was inaugurated for launching Biocon’s insulin glargine pen –Basalog One in India.

The company has sets its sight on the capturing a significant share of the $144 million worth Japanese glargine market which is the second largest market outside North America and Europe and is a wide market of disposable pens.

Biocon is renowned as an Asia’s largest Insulins producer and has maintained the status through their innovative products at affordable costs. Their recombinant human insulin and analogs in the market and the key brands – INSUGEN® (rh-insulin), BASALOG® (glargine) speaks volume about the company’s credibility and success. Currently the company has marketing approvals for rh-insulin in over 60 countries and in over 20 countries for insulin glargine.

Figure 1 & Featured image credit. Adaptation from SANOFI DIABETES Lantus® insulin glargine 

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