Biocon set for bigger insulin play, aims to reach one in five diabetics

Biocon Biologics CEO says portfolio to form a substantial part of $1 bn revenue target, to roll out insulin Aspart by next year

Biopharmaceutical major Biocon is on a high. It recently rolled out insulin Glargine at the lowest market price in the US which opens up a $2.2 billion opportunity for the R&D focused company.

While Biocon has entered over 40 countries with its two offerings in the insulin portfolio namely recombinant human insulin (rh-insulin) and insulin Glargine, the Bengaluru-based company is aiming to reach one in five diabetes patients in need of insulin-based therapy around the globe.

“A blockbuster is not earning $1 billion in revenue but touching the lives of 1 billion patients. We call diabetes a global pandemic which affects almost 500 million people around the world today,” says Christiane Hamacher, CEO and MD of Biocon Biologics.  It was Biocon which came up with the first global human insulin based on a Pichia expression system.  

 

In the late 90s, 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 company came up with its first insulin offering called Insugen at one tenth the cost of insulin that was imported from Western nations. 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 company has built Asia’s largest integrated insulin manufacturing facilities in Malaysia to drive economies of scale, enabling it to scale up and meet the growing demand of insulin around the globe. The company received the Establishment Inspection Report from the USFDA for the 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 and is planning the next phase of investment as it expands capacity to meet the demand coming in, especially from the US.

The company has also made the commitment to bring down the prices of insulin to Rs 7 per day for low and middle income countries (LMICs) including India for which it is in discussions with several governments. 

“Our scientific knowledge and manufacturing capabilities allow us to produce with efficiency in productivity and at such a scale that the insulin at Rs 7 per day is a profitable business for us,” says Hamcher. 

Touching a revenue of over Rs 650 crore, the biologics arm of Biocon, which includes the insulin portfolio, aims to become a $1 billion business and impact 5 billion lives by FY22. “The insulin portfolio will form a substantial part of these objectives,” says 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 a $78 billion opportunity. While Biocon’s rh-inulin and insulin Glargine are available in several developed and developing economies, the company is working on a pipeline of two more products in the insulin 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 is likely to pick up which will help Biocon establish itself as a key insulin player globally,” says pharma expert Ranjit Kapadia. 

Going beyond medicine, Biocon has also paired its diabetes therapy with digital therapeutics. Its Malaysian subsidiary has collaborated with France-based healthcare solutions company Voluntis to develop and distribute a digital product called Insulia for diabetic patients which will be rolled out in a couple of months in the market. 

Biocon's insulin portfolio

Products in market: rh-insulin, Glargine

Products in pipeline: Aspart, Lispro

Digital play: To offer app Insulia for self-management of the disease

Footprint in over 45 countries

Owns Asia’s largest integrated insulin unit in Malaysia