Biocon shares surge 3% as subsidiary obtains USFDA approval for diabetes drug

Biocon shares surged 3% to an intraday high of Rs 401.55 on the BSE on Wednesday, after its subsidiary, Biocon Biologics, secured the U.S. Food and Drug Administration (FDA) approval for Kirsty (Insulin Aspart-xjhz), 100 units/mL.

This marks a significant milestone as Kirsty is the first and only interchangeable biosimilar to NovoLog (Insulin Aspart) in the United States.

Kirsty, a rapid-acting human insulin analogue, is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It will be available in a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.


This FDA approval significantly expands Biocon Biologics’ biosimilar insulin portfolio in the U.S., which already includes Semglee (Insulin Glargine-vfgn Injection), the first approved interchangeable biosimilar, available in Europe and Canada since 2022.

The news comes as the U.S. faces a substantial diabetes burden, with 38.4 million people diagnosed, representing approximately 11.6% of the total population. A significant portion, nearly a quarter, remain undiagnosed, and an additional 97.6 million Americans are identified as prediabetic.

The U.S. market for Insulin Aspart alone saw approximately $1.9 billion in sales in 2024.

Biocon Biologics is already a global leader in biosimilars and insulin production, ranking among the top three global players for rh-Insulin and Insulin Glargine. The company has provided over 9.2 billion doses of insulin globally, with a broad portfolio of basal, mixed, and rapid-acting insulins.

Globally, Biocon Biologics serves over 5.8 million patients annually and boasts a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies.

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This includes eight products in the United States and seven in Canada, with a robust portfolio of 20 biosimilar assets spanning multiple therapy areas, including insulins and monoclonal antibodies.

On Tuesday, Biocon shares closed 3% higher at Rs 390.20 on the BSE.

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