Biocon’s insulin glargine gets Japanese approval

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Hyderabad: Shares of Biocon Ltd rose in a weak market after the biopharmaceutical firm said it has received approval to sell its biosimilar insulin glargine in Japan.

“The approval for insulin glargine has been obtained post successful completion of initial development of Biocon and local phase-III clinical studies in over 250 type-1 diabetes patients by our partner in Japan,” Biocon said in a statement. Insulin glargine is a long-acting form of insulin to treat diabetic patients.

The company said it aims to capture a significant share of the Japan’s $144 million glargine market—the second largest outside North America and Europe.

Biocon has tied up with Fujifilm Pharma Co. Ltd to develop and commercialize the product in Japan. It plans to launch insulin glargine in Japan in the first quarter of the next financial year.

Biocon’s product will come in ready-to-use, prefilled disposable pens with 3 ml of 100 IU insulin glargine.

“The insulin glargine approval in the highly regulated market like Japan marks a huge credibility milestone for Biocon,” company chairperson and managing director Kiran Mazumdar-Shaw said.

“We see this as a significant achievement in our journey of making a global impact in diabetes management through our affordable biosimilar insulins,” Mazumdar-Shaw added.

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.

The per capita spending on pharmaceuticals in Japan is the second highest among OECD (Organisation for Economic Co-operation and Development) countries after the US, and the government is striving to rationalize healthcare spending by encouraging the entry of high quality yet affordable follow-on biologics.

Biocon markets human insulin or rh-Insulin and insulin glargine 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 NV.

Shares of Biocon gained 3.59% to close at Rs.479.05 on Monday on the BSE, while the benchmark Sensex closed down 371.16 points, or 1.46%, at 24,966.40.