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C.R. Sukumar

The Biocon CMD, Ms Kiran Mazumdar-Shaw

Hyderabad , Nov. 29

CLOSE on the heels of launching the world's first recombinant human (r-DNA) insulin, Biocon Ltd is now waiting for the US Food and Drug Administration (USFDA) to spell out its regulatory policy on the generic version of insulin so that the company could foray into the US market at the earliest.

Disclosing this to Business Line here, the Biocon Chairman and Managing Director, Ms Kiran Mazumdar-Shaw, has said the regulatory barriers in the US and the European markets were currently less clear and that the USFDA was yet to decide on allowing the generic insulins into the US market.

"They are supposed to make some announcement very soon on the issue," she said.

According to her, the company is currently in the process of filing registrations for its bio-insulin product in 20 different countries.

It has already made its first supply to Egypt and is looking at West Asia, South Asia, South-East Asia, Latin America and China.

"These are all very important markets for us in the near term. The US and the European markets would be our long-term targets in view of regulatory barriers."

Stating that Biocon has already submitted a drug master file to the USFDA and became the first Indian insulin producers to do so, Ms Mazumdar-Shaw said, "We would like to hasten the registration process in the US. However, the USFDA is not clear whether it should allow abbreviated new drug application (ANDA) or new drug application (NDA) for generic insulin. They have still not made up their mind and the regulatory procedures are yet to be decided."

Ms Shaw finds large market potential for insulin especially in view of the inhaled insulins coming into the picture.

"Once inhaled insulin comes in, the quantity and requirement of insulin is going to be very large. And I think we will really have a global edge in that. Our product meets the highest global standards and Bristol Myers-Squibb has endorsed it."

Biocon is currently exploring and developing oral insulin in alliance with the US-based Nobex Corporation.

"It will take at least 12 months for us to arrive at proof of concept and another 12 months for developing the final product," Ms Mazumdar-Shaw said.

Terming the bio-insulin as one of the important product for the company, she said the company was aiming at garnering at least 20 per cent of the Indian insulin market over the next three years. The market, currently at over Rs 200 crore, is expected to grow to around Rs 300 crore in the next three years. Biocon expects to record volumes in the range of Rs 50 crore-60 crore from bio-insulin, she said.

Objecting to the popular view and mindset that Biocon is a statins company, Ms Mazumdar-Shaw said, "Statins are important for us but we do realise that it is only a short-term opportunity for us. The medium-term opportunity is in insulins. And then we find long-term opportunity in anti-bodies and proprietary molecules. We will focus on statins, insulins, anti-bodies and immuno-suppressants."

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