Liraglutide biosimilar(Biocon Limited)

New Delhi: Biotech firm Biocon on Tuesday said it has received approval from the government authorities for a generic diabetes medication . The company has received approval for its Liraglutide drug substance and its wholly-owned subsidiary Biocon Pharma has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India ( CDSCO ). The approval is for the generic version of Victoza , indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise, the company said in a regulatory filing. "The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further, he added. "We are now gearing up to launch the product expeditiously through our commercialisation partners in India," Mittal stated. Biocon shares were trading 0.81 per cent up at Rs 336.75 apiece on BSE.

On May 11, 2025, Biocon, a leading biopharmaceutical company, revealed plans to invest $150 million in capital expenditure (capex) over the next two years. The investment includes $100 million for its biologics division, with a significant portion allocated to expanding manufacturing capacity in Malaysia, and $50 million for generics. Biocon’s CEO, Siddharth Mittal, confirmed that the generics capex program will largely conclude next year, leaving only minimal maintenance spending thereafter. Meanwhile, Biocon’s biologics capex will moderate after this expansion phase. The announcement followed Biocon’s Q4 earnings report, which showed a 153% surge in net profit to ₹344 crore and a 12% increase in consolidated revenue to ₹4,454 crore. Key drivers included biosimilars, generics growth, and strong demand in research services. Biocon recently launched lenalidomide and dasatinib in the US, along with liraglutide in the UK, bolstering its oncology and diabetes portfolios. The company is eyeing the launch of bevacizumab in the US later this year, alongside anticipated approval for insulin aspart. With four biosimilars each generating $200 million in FY25 sales, Biocon is strengthening its foothold in global markets. It also launched ustekinumab, a biosimilar to Stelara, in the US and expanded its biologics manufacturing footprint through a facility acquisition. To support its growth plans, Biocon is raising ₹4,500 crore via QIP and private placements, aimed at meeting financial obligations and funding biologics investments.