Biocon gets USFDA nod for key diabetes treatment drug; stock gains

16 Jul 2025 , 12:08 PM

Biocon Ltd. shares zoomed as much as 3% in its early trading session on July 16, after the company received United States Food & Drug Administration (USFDA) approval for Insulin Aspart, which the company brands as Kristy.

Kristy is a fast-working human insulin biosimilar used to improve glycemic control in adults and pediatric patients with diabetes mellitus. 

The company said that the insulin will now be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.

As per the company’s regulatory filing, Kristy is currently available in the European Union and Canada markets from 2022.

The company has received approval for the first and only interchangeable biosimilar to Novolog. As per the IQVIA data for 2024, the insulin witnessed sales of about $1.19 Billion in the US markets.

The company announced in its statement that FDA approval of Kristy expands the insulin portfolio of Biocon Biologics. The company’s portfolio includes the first approved interchangeable biosimilar, Semglee (Insulin Glargine-yfgn injection).

At around 12.00 PM, Biocon was trading 1.34% higher at ₹395.70, against the previous close of ₹390.45 on NSE. The counter touched an intraday high and low of ₹405.90, and ₹393.20, respectively.

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