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# Biocon’s Interchangeable Insulin Approved
- URL: https://www.fdaweb.com/biocons-interchangeable-insulin-approved/
- Published: 2025-07-15T12:00:00.000Z
- Updated: 2026-09-14T15:16:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159506

FDA has approved a Biocon Biologics BLA for its rapid-acting interchangeable biosimilar insulin product, [Kirsty (insulin aspart-xjhz)](https://links-2.govdelivery.com/CL0/http:%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda%5Fdocs%2Flabel%2F2025%2F761188s001lbl.pdf%3Futm%5Fmedium=email%26utm%5Fsource=govdelivery/1/010101980eed9624-45141b29-9c50-4192-97b7-7473f022b063-000000/g386vz7DNMHQqECReekxos%5FtTuKgNVZea7KTPiYdSYk=413?ref=fdaweb.com), a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novo Nordisk’s Novolog (insulin aspart). Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus, according to an FDA news release. 

“Dosing of Kirsty, like Novolog, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin aspart products,” the release says. “Kirsty may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium in your blood). The most common side effects associated with insulin aspart products other than hypoglycemia include, lipodystrophy (pitting at the injection site), weight gain and allergic reactions, such as injection site reactions, rash, redness, pain and severe itching.”