Purple Book product · Interchangeable

Kirsty

insulin aspart-xjhz

351(k) InterchangeableBLA 761188RxLicensed Biocon Biologics Inc.

View insulin aspart family Label PDF Open on FDA Purple Book

Jul 15, 2025

Approved

Interchangeable

License type

Marketing

None

Listed patents

Kirsty (insulin aspart-xjhz) is a Interchangeable referencing insulin aspart, licensed under a 351(k) BLA in 2025 and marketed by Biocon Biologics Inc.. As an interchangeable biosimilar it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Jul 15, 2025
1 yr ago
Today
First interchangeable exclusivity ends
Window blocking subsequent interchangeable approvals for the reference product.
Sep 15, 2026
in 2 mo

Pharmaceutical detail

Strength

1,000UNITS/10ML (100UNITS/ML)

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Multi-Dose Vial

Center

CDER

License number

2324

Product number

002

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of insulin aspart (Novolog)

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Is Kirsty a biosimilar?

Yes. Kirsty is a Interchangeable referencing insulin aspart, licensed under a 351(k) BLA.

Is Kirsty interchangeable?

Yes. Kirsty carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

What is Kirsty's BLA number?

Kirsty is licensed under BLA 761188, held by Biocon Biologics Inc..

When was Kirsty approved by the FDA?

Kirsty was approved by the FDA on Jul 15, 2025.

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