Biocon bets on Biosimilars, GLP-1 portfolio to drive next phase of growth

Biocon is preparing for expansion across its biologics, generics, and research services business segments, with a strategic focus on biosimilars and the emerging GLP-1 therapy segment.

“Today, biosimilars are an important part of our business, contributing almost 65% of revenues,” Siddharth Mittal, Managing Director and CEO of Biocon, told Business Today.

He highlighted upcoming launches in the US, Europe, and Canada, including the recently approved Bevacizumab and Insulin Aspart by the US FDA. Insulin Aspart is the first and only interchangeable rapid-acting biosimilar insulin to be approved.

The company has launched Yesafili as the first biosimilar Aflibercept in Canada and has received a positive opinion from EMA in Europe. Its biosimilar Denosumab has been granted approval by both EMA and the UK MHRA, while its biosimilar Ustekinumab has been approved by the UK MHRA.

All these products will be commercialised going forward. “The combination of new launches and increasing market share for existing products continues to build momentum,” he added.

Biocon currently has 10 biosimilar products commercialised globally and has a few approvals, which prepare it well for future launches. Beyond biosimilars, Biocon sees opportunities in expanding the reach of its insulin portfolio, particularly as innovators shift focus to GLP therapies. “This opens the possibility for us to bring our insulins to many more patients worldwide. We see supportive trends in the insulin business,” Mittal noted.

In the generics segment, Biocon is making a strategic push into GLP-1 drugs, including Liraglutide, Semaglutide, and Tirzepatide. The company has launched Liraglutide in the UK and EU and has secured approvals for Liraglutide in India recently.

Filings for Semaglutide and Tirzepatide are underway in select markets, with launches expected in 2027, said Mittal. Apart from GLP-1, Biocon’s existing generics portfolio, which includes oral solids and injectables, continues to grow across the US and other markets.

“While the GLP-1 segment is competitive, very few companies have approvals for Liraglutide, and none have yet received approval for a generic Semaglutide,” Mittal said. He highlighted Biocon’s vertical integration, covering drug substance, drug product, and drug-device combinations, as a key differentiator.

“We also have a strong commercial infrastructure and collaborations with local partners in markets such as Latin America and the Middle East. Overall, we are well-positioned to capitalise on opportunities in GLP-1s for the generics business,” he added.

“GLP-1 will be a key revenue contributor for us. We have a portfolio of 10 GLP-1 products, including Semaglutide and Tirzepatide. Scientifically, we are confident about receiving approvals from various regulators for these,” he said.

To support these ambitions, Biocon has commissioned a state-of-the-art GLP-1 injectable facility in Bengaluru, which will cater to both domestic and export markets and is expected to commercialise in FY27. “Our philosophy is to bring drugs to all patients under a single quality system,” Mittal explained.

This facility will fulfil business needs across vials, cartridges, prefilled syringes, and drug-device combination products, strengthening our capacity to serve portfolio demands globally,” he said.

The company is also focused on strategic capital deployment. It has already invested in GLP-1 drug substance and drug product facilities. In the case of insulins, the company has already doubled its drug product capacity in Malaysia and is planning to further expand drug substance capacity over the next few years.

“With these investments, the majority of CapEx for the next 2–3 years is complete. We will now focus on maintenance CapEx,” Mittal said.

Earlier this year, Biocon raised ₹4,500 crore through a QIP, allowing it to meet obligations to structural investors and increase its stake in Biocon Biologics from 72% to 78% on a fully diluted basis. In Q1 FY26, Biocon reported revenue of ₹4,022 crore, with biosimilars rising 18%, generics up 6%, and its CRDMO (formerly research services) segment up 11%.

EBITDA grew 19% to ₹829 crore. Key generic product milestones for Biocon in the quarter included the launch of Liraglutide in the EU, as well as the approvals of Dasatinib, Lenalidomide, Micafungin, and Everolimus in the US.

In India, the recent approval of Liraglutide marks it as the company’s first GLP-1 product in the country, which will be commercialized through its partners. This quarter, Biocon also received US FDA approval for Rivaroxaban tablets.

Additionally, Brazil’s ANVISA cleared its three API manufacturing sites with zero observations, further strengthening the company’s global production and regulatory footprint.