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FDA Approves First Interchangeable Biosimilar Insulin Product to Novolog (insulin aspart)
Today, the Food and Drug Administration approved, the first rapid-acting interchangeable biosimilar product, Kirsty (insulin aspart-xjhz), as a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novolog (insulin aspart).
Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference product. As a biosimilar product, Kirsty (insulin aspart-xjhz) can be used in place of Novolog (insulin aspart). As an interchangeable biosimilar, Kirsty may be substituted at the pharmacy for the reference product, depending on state laws.
The Kirsty 3 mL prefilled pen is administered subcutaneously and the Kirsty 10 mL vial is administered subcutaneously, by continuous subcutaneous infusion (insulin pump), or intravenously. 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. Kirsty may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium in your blood) e. 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.
Kirsty (insulin aspart-xjhz) is the 72nd biosimilar product approved in the U.S., and the 4th biosimilar insulin product approved in the U.S.
This approval furthers FDA’s longstanding commitment to support a competitive marketplace for insulin products. The availability of biosimilar and interchangeable insulin products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients.
For more information about biosimilar products, visit www.fda.gov/biosimilars.
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