Kirsty FDA Approval History

Last updated by Judith Stewart, BPharm on July 15, 2025.

FDA Approved: Yes (First approved July 15, 2025)
Brand name: Kirsty
Generic name: insulin aspart-xjhz
Dosage form: Injection
Company: Biocon Biologics Inc.
Treatment for: Diabetes Mellitus

Kirsty (insulin aspart-xjhz) is a rapid acting human insulin analog interchangeable biosimilar to NovoLog (insulin aspart) indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

• Kirsty is is approved in the following presentations:
  

  Product Presentation	Strength	Biosimilar / Interchangeable
  Multi-Dose Vial (Subcutaneous Injection)	100 units/mL (U-100) 10 mL	Interchangeable
  Prefilled Pen (Subcutaneous Injection)	100 units/mL (U-100) 3 mL	Interchangeable

• Kirsty is administered by subcutaneous injection.
• FDA approval of Kirsty was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that Kirsty is highly similar to NovoLog. The data demonstrated that there were no clinically meaningful differences between Kirsty and NovoLog in terms of safety, efficacy, purity and potency.
• Warnings and precautions associated with Kirsty include hyperglycemia or hypoglycemia with changes in insulin regimen, hypoglycemia which may be life-threatening, hypersensitivity reactions, and hypokalemia.
• Adverse reactions observed with insulin aspart products include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.
• Kirsty is the second FDA-approved biosimilar to NovoLog.

NovoLog Biosimilars

Development timeline for Kirsty

Further information

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