Biocon shares hit 52-week high after firm gets USFDA nod for diabetes medication

Pharma major Biocon Ltd shares jumped nearly 3% on Wednesday, July 16, after receiving a significant regulatory boost from the USFDA. The stock touched a new 52-week high at ₹405.90, drawing investor attention to the company’s latest milestone.

Biocon Biologics, the biosimilars arm of Biocon Ltd received USFDA’s approval for its rapid-acting insulin biosimilar, Kristy. This marks a crucial development, as Kristy becomes the first and only biosimilar deemed interchangeable with NovoLog (Insulin Aspart), a vital diabetes therapy.

Kristy is a fast-acting human insulin analog intended to improve glycemic control in adults and children with diabetes mellitus. As part of its offering, the drug will be available in a single-patient-use prefilled pen for subcutaneous administration, as well as a multiple-dose vial for both subcutaneous and intravenous use.

This approval further strengthens Biocon Biologics’ insulin biosimilar portfolio, which already includes Semglee (Insulin Glargine-yfgn Injection)--another USFDA-approved interchangeable biosimilar. Kristy, notably, has already been available in European and Canadian markets since 2022.

"The FDA approval of Kristy expands Biocon Biologics' biosimilar insulin portfolio, which also includes the first approved interchangeable biosimilar, Semglee (Insulin Glargine-yfgn injection)," the company's statement said.

Shreehas Tambe, MD & CEO of Biocon Biologics, said that the USFDA approval marks a major milestone in the company’s mission to enhance insulin accessibility and affordability.

Currently, shares of Biocon are trading at ₹396.16 apiece on the National Stock Exchange, rising 1.63%.

For Q4 FY25, Biocon Ltd had reported a net profit zoomed 154% to ₹344.5 crore, compared to ₹135.5 crore a year earlier. Its revenue increased 12.8% year-on-year (YoY) to ₹4,417 crore.

For the quarter, Biocon’s earnings before interest, taxes, depreciation, and amortisation (EBITDA) surged 17.7% YoY to ₹1,078.2 crore as against ₹915.9 crore in the same quarter last year. The margin also expanded to 24.4% from 23.4% a year ago.

Biocon had declared a final dividend of ₹0.50 per share (10%) with an effective date of July 4, 2025. It has previously issued bonuses, including a 1:1 bonus declared on April 25, 2019, with an ex-bonus date of June 12, 2019.