India's premier biopharmaceutical company Biocon is working on a pipeline of 20 biosimilar drugs or similar but not identical copy of biologic medicines, to tap the upcoming huge opportunity.

Biocon, which launched the world's first interchangeable insulin Glargine in the US during the third quarter, has eight approved products. It has biosimilars in oncology like Pegfilgrastim, Trastuzumab, Bevacizumab and Pertuzumab, Adalimumab and Etanercept in immunology and diabetic products like Glargine, Aspart and RHI.

"We are working on about 20 biosimilars, but cannot disclose the entire pipeline for competitive reasons. Growth in the Biocon group is going to be led by biosimilars because that is already our biggest business, which has the greatest growth potential for the foreseeable future and going to give us very strong growth over the coming years," Kiran Mazumdar Shaw, chairperson of Biocon, told Fortune India in an exclusive interview.

According to a McKinsey estimate, biosimilar global sales topped $15 billion in 2020, representing a compound annual growth rate (CAGR) of 56% since 2015. The market is set to continue its double-digit growth, doubling in size to more than $30 billion by 2025, and over $60 billion by the end of the decade.

In the third quarter of FY22, Biocon had 28% increase in revenues from biosimilars to ₹981 crore, mainly led by commercialisation of insulin Glargine in the US and strong performance in emerging markets. "We are already getting good contributions from biosimilars such as Trastuzumab, Pegfilgrastim and in Europe, we have Bevacizumab, Aspart and Adalimumab. Adalimumab will enter the US very shortly. Though Covid has delayed regulatory inspections, we expect to get Bevacizumab and Aspart get approval in FY23 and that will continue to add to the biosimilars approval pipeline." she says.

Biocon's research in biosimilars is not focussed on any particular disease segment or focus area though it has developed several biosimilars in oncology and diabetics. "We look at opportunities which are large and where we have a competitive advantage", she says.

Biocon's generics business, with focus on high value complex generics, is also growing. In the third quarter, the company had ₹607 crore revenues, an increase of 7% over the corresponding quarter last year, thanks to the launch of Everolimus in the US and growth in active pharmaceutical ingredient (API) business. "Everolimus was a first day launch for us and that has already grown to over 35% market share in that particular segment. There are many other products that have been approved this quarter and will be approved in the coming quarters," says Kiran.

She said Biocon's partnership with Serum Institute of Life Sciences (SILS) gives the company an opportunity to leverage Biocon's R&D capabilities and Serum's manufacturing capabilities in vaccines to tap and develop novel vaccines for global markets. "The business partnership is about $400 million of top line and about $100 million of bottom line with guarantee for five years. That itself gives you an idea of the size and scale of the partnership", she says.

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