insulin aspart (Fiasp)
insulin aspart is an FDA-licensed reference biologic from Novo Nordisk Inc., with 2 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
1
Biosimilars
1
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
Fiasp insulin aspart
Novo Nordisk Inc.
- Approved
- Jun 21, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin aspart, in chronological order.
Reference approval
Approval date of the reference insulin aspart product.
3 yr ago
Biosimilars & interchangeables for insulin aspart
2 FDA-licensed follow-on biologics referencing insulin aspart.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Merilog | insulin aspart-szjj | Sanofi-Aventis U.S. LLC | Biosimilar 351(k) | 761325 | Feb 14, 2025 |
| Kirsty | insulin aspart-xjhz | Biocon Biologics Inc. | Interchangeable | 761188 | Jul 15, 2025 |
Frequently asked questions
What biosimilars are approved for insulin aspart (Fiasp)?
The FDA Purple Book lists 2 approved follow-on biologics referencing insulin aspart: Merilog and Kirsty. Of these, 1 is an interchangeable biosimilar and 1 is a 351(k) biosimilar.
Is there an interchangeable biosimilar for insulin aspart?
Yes. Kirsty is approved as interchangeable biosimilar for insulin aspart, meaning it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
Who makes insulin aspart biosimilars?
Companies with FDA-approved follow-on biologics referencing insulin aspart include Sanofi-Aventis U.S. LLC and Biocon Biologics Inc..
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.