Pharma major Biocon Ltd's shares hit a fresh 52-week high in trade on Wednesday, July 16, after the firm's subsidiary received approval from regulator U.S. Food and Drug Administration for Kristy, the company's branded version of diabetes drug Insulin Aspart.
Kristy is a rapid-acting human insulin analog, indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
At 11.10 a.m., Biocon shares were quoting Rs 395.55, up 1.3 percent on the NSE. Earlier in the session, it had reported a strong rally, jumping over three percent to record a fresh 52-week high at Rs 405.9 apiece.
Biocon, in a regulatory filing, announced that the product will now be offered in a single-use prefilled pen for subcutaneous administration, as well as in a multi-dose vial suitable for both subcutaneous and intravenous use.
Kristy has been available in the European Union and Canada since 2022. This approval marks the first and only interchangeable biosimilar to Novolog. As per IQVIA’s 2024 data, Insulin Aspart generated nearly $1.9 billion in sales in the United States.
In a filing with the bourses, the firm added that "the FDA approval of Kristy expands Biocon Biologics' biosimilar insulin portfolio, which also includes the first approved interchangeable biosimilar, Semglee (Insulin Glargine-yfgn injection)."
Shreehas Tambe, CEO and managing director, Biocon Biologics said, “The FDA approval of Kirsty, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the US, is a significant step forward in our efforts to make insulin more accessible and affordable.
"With Kirsty, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care,” he added.
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