Biocon gears up for a bigger insulin play

Biopharmaceutical major Biocon is on a high. It recently rolled out insulin Glargine at the lowest price in the US market, opening up a $2.2 billion opportunity.

Biocon has entered over 40 countries with its two offerings in the insulin portfolio, namely recombinant human insulin (rhinsulin) and insulin Glargine. The firm is aiming to reach one in five diabetics in need of insulin-based therapy around the globe.

“A blockbuster is not earning $1 billion in revenue but touching the lives of a billion patients. We call diabetes a global pandemic. It affects 500 million people around the world today,” said Christiane Hamacher, a scientist who heads the firm’s biologics business. It came up with the first global human insulin based on a pichia expression system.

In the late 1990s, Biocon, which had started as an enzymes business, was looking to diversify to make an impact on a larger patient population. It started analysing and repurposed its fermentation platform based on a yeast species called pichia pastoris to start developing recombinant human insulin protein. In 2004, after four years of R&D, the firm came up with its first insulin offering, Insugen, at one tenth the cost of insulin that was imported from the West. As a result, the prices of insulin crashed domestically and it was later brought under price control, which made India one of the most affordable insulin markets globally.

Since then, the firm has built Asia’s largest integrated insulin manufacturing facility in Malaysia to drive economies of scale, enabling it to scale up and meet the growing demand of insulin around the globe. It received the Establishment Inspection Report from the USFDA for pre-approval inspection of its facility in

Malaysia for insulin Glargine in April.

Biocon has already made a capital expenditure of $250 million in the facility so far. It is planning the next phase of investment as it expands capacity to meet the demand, especially from the US.

The firm has also made a commitment to bring down the prices of insulin to ~7 per day for low and middle income countries, including India, for which it is in discussions with several governments.

“Our scientific knowledge and manufacturing capabilities allow us to produce with efficiency so that the insulin, at ~7 per day, is a profitable business for us,” said Hamcher.

Touching a revenue of over ~650 crore, the biologics arm, which includes the insulin portfolio, aims to become a $1 billion business and impact 5 billion lives by FY22.

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“The insulin portfolio will form a substantial part of these objectives,” said Hamacher.

From 151 million in 2000, the prevalence of diabetes has risen to 463 million or 9.3 per cent of the global population in 2019. By 2026, reports suggest the diabetes market is expected to become $78 billion.

While Biocon’s rh-insulin and insulin Glargine are available in several developed and developing economies, the drugmaker is working on a pipeline of two more products in the portfolio — namely Aspart and Lispro, both rapid acting insulin analogs.

It has already done the regulatory submission for biosimilar Aspart, which is now under review with the US regulator and is expected to be launched next year.

“With more and more approvals in the segment in various countries, sales will most likely pick up. This will help Biocon establish itself as a key insulin player globally,” said Ranjit Kapadia, a pharma expert.