Pharmaceuticals major Biocon has carved out a strategic shift in its growth plan with biosimilar drugs expected to garner more than a quarter of its revenues over the next five years.
Biosimilar medicines, which include insulin and various vaccines, are made through biological processes and not by chemical synthesis.
At present, biosimilar drugs account for about 10 per cent of the company’s revenues.
Biocon plans to tap the emerging markets of Latin America, North Africa, China, Korea, India and Russia with its range of biosimilar products.
“The market for biosimilar products is growing at around 30 per cent per annum in the emerging markets, which will bolster growth,” Kiran Mazumdar-Shaw, chairman and managing director of Biocon, told Hindustan Times. As the regulatory framework for biosimilar products becomes clear in developed countries in the US and Europe, the company would expand its presence in those markets, she said.
The market for biosimilar products in emerging countries is estimated at around Rs 4,600 crore and the same accounts for around Rs 750 crore in India.
The regulatory path for biosimilar drugs is more challenging than the chemically synthesised generic drugs, since the pharma company needs to prove clinical efficacy and efficiency in order to manufacture a biosimilar product.
Approvals for the manufacture of biosimilar products are granted only after a firm shows abilities to conduct clinical trials and that its biosimilar medicine is comparable and not inferior to the innovator product.
“Insulin and antibodies offer the biggest opportunities in biosimilar drugs,” Shaw said.