Biocon shares near 52-week high after USFDA approves key diabetes treatment drug

Shares of Biocon Ltd. gained as much as 3% in early trading on Wednesday, July 16, after the United States Food & Drug Administration (USFDA) approved Insulin Aspart, which the company brands as Kristy.Kristy is a rapid-acting human insulin analog, indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It will now be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use, Biocon said in its exchange fling.
Currently, Kristy is available in the European Union and Canada markets since 2022. The approval is for the fist and only interchangeable biosimilar to Novolog. According to IQVIA data for 2024, Insulin Aspart had total sales worth nearly $1.9 billion in the US market.
“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, the MD & CEO of Biocon Biologics said that the USFDA approval is a significant step forward in the company’s efforts to make insulin more accessible and affordable.

“Considering the market size, competition, acceptability of biosimilars and time taken to add to formulary, we expect annual sales worth $80 million to $100 million post addition to formulary,” brokerage firm Motilal Oswal said in a note.

Shares of Biocon are up 2.7% on Wednesday at ₹401.7. The stock had gained 2.9% on Tuesday as well and are trading close to their 52-wek high of ₹404.7. As of Tuesday’s close, the stock was up 10% in the last one month.