The shares of the prominent pharmaceutical company gained up to 4 percent in today’s trading session after the company expanded its diabetes portfolio with the USFDA Approval.

With a market capitalization of Rs 52,950.44 crore, the shares of Biocon Ltd were trading at Rs 396.05 per share, increasing around 1.50 percent as compared to the previous closing price of Rs 390.20 apiece.

US FDA Approval

The shares of Biocon Ltd have seen bullish movement after announcing that the U.S. Food and Drug Administration (FDA) has approved Kirsty, 100 units/mL, as the first and only interchangeable* biosimilar to NovoLog (Insulin Aspart).  

Moreover, KIRSTY is a fast-acting human insulin analog designed to enhance glycemic control in both adults and children with diabetes mellitus. Offered in a prefilled pen for subcutaneous use and a multi-dose vial for both subcutaneous and intravenous use, it supports flexible and effective diabetes management across diverse clinical settings.

Furthermore, FDA approval of KIRSTY strengthens Biocon Biologics’ biosimilar insulin portfolio, complementing its earlier success with Semglee, the first approved interchangeable biosimilar. Already available in Europe and Canada since 2022, KIRSTY’s U.S. entry marks a significant milestone, enhancing global access to affordable insulin therapies for diabetes management.

Additionally, With 38.4 million diabetics and $1.9 billion in U.S. Insulin Aspart sales in 2024, the diabetes burden is significant. Biocon Biologics, a global biosimilars leader, ranks among the top three insulin producers, delivering over 9.2 billion doses worldwide with a comprehensive insulin portfolio including basal, mixed, and rapid-acting variants.

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Financial & operational Highlights

Looking forward to the company’s financial performance, revenue increased by 13 percent from Rs 3,917 crore in Q4FY24 to Rs 4,417 crore in Q4FY25. Furthermore, during the same time frame, the net profit increased by 106 percent, from Rs 223 crore to Rs 459 crore.

Biocon Group operates in 120+ countries and has a market cap of USD 4.7 bn. Its four businesses, Biocon Biologics, Biocon, Syngene, and Bicara, drive innovation in biosimilars, generics, research services, and novel biologics, contributing 58%, 19%, 23% of FY25 revenue, respectively.

Biocon Limited focuses on treating diabetes, cancer, and autoimmune diseases. Its segment includes Generics, Biosimilars, Novel Biologics, and Research Services. It has developed and commercialized novel biologics, biosimilars, and complex small-molecule active pharmaceutical ingredients (APIs) in India and several key global markets.

Written by Abhishek Singh

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