Biocon to launch two insulin variants in Malaysia in fiscal 2017

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Hyderabad: Biocon Ltd on Friday said it plans to launch recombinant human (rh)-insulin and long-acting insulin glargine in Malaysia in the second half of this financial year, after it received regulatory approval from the South-East Asian nation.

According to Biocon, the insulin market in Malaysia is pegged at around $40 million including sales from tenders and retail. The Malaysian approval comes months after Japanese approval for Biocon’s insulin glargine, providing a fillip to the company’s efforts of launching biosimilars in other markets.

The company last week said its partner FUJIFILM Pharma Co. Ltd has launched insulin glargine in Japan. Shares of Biocon rose 15.28% to Rs.808.70 on BSE, on a day when the benchmark Sensex gained 0.33% to end at 27,803.24 points.

Biocon’s rh-insulin will become the first product to be manufactured at the company’s upcoming integrated insulin facility at Johor in Malaysia, where the company is investing around $160 million. Insulin glargine will initially be manufactured and shipped to Malaysia from Biocon’s Bengaluru facility, before the new facility starts producing it.

“The approval will open up commercialization opportunities for the company and will enable us to address the needs of nearly 3.3 million diabetes patients in Malaysia,” Biocon said. The company said regulatory filings for several other markets are underway to enable commercial sales from the Malaysian facility.

The Malaysian facility will help Biocon address capacity concerns in India, and allow the company to expand its market share in rh-insulin and insulin glargine. Currently Biocon has 10% market share in rh-insulin and 15% for insulin glargine, in a market dominated by Denmark-based Novo Nordisk A/S, France-based Sanofi SA and US-based Eli Lilly & Co.

Biocon, which has marketing approvals in over 60 countries for rh-Insulin and in over 20 countries for insulin glargine, said it is targeting the top 20 emerging markets including Brazil, Russia, China and South Africa.

“Our aim is to quickly open these emerging markets,” said Kiran Mazumdar-Shaw, chairperson and managing director of Biocon. She declined to give a specific timeline for any of these markets, saying that approvals depend upon regulators and data submitted.

Insulin glargine and breast cancer drug trastuzumab are major contributors in terms of sales for Biocon. In the fiscal first quarter, the biologics division reported sales of Rs.107 crore, growing at 53%.