Regulatory Authority: U.S. Food and Drug Administration (USFDA)
Regulatory Event: BLA Approval – Interchangeability
Product: Garzulys (insulin aspart-fsan) injection
BLA: 761497/Original 2
Approval Date: September 15, 2026
Reference ID: 5869336
Regulatory Update
The U.S. Food and Drug Administration (FDA) has approved BLA 761497/Original 2 for Garzulys (insulin aspart-fsan) injection as an interchangeable biosimilar product. The application was submitted under Section 351(k) of the Public Health Service Act.
Garzulys is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
Key Product Details
The original BLA covered the following presentations:
- 10 mL, 100 units/mL multiple-dose vial for subcutaneous use
- 10 mL, 100 units/mL multiple-dose vial for intravenous use
- 3 mL, 100 units/mL single-patient-use prefilled pen for subcutaneous use
These presentations were developed as biosimilar to and interchangeable with the corresponding U.S.-licensed NovoLog (insulin aspart) presentations.
Regulatory Significance
For administrative purposes, FDA divided BLA 761497 into two parts:
- BLA 761497/Original 1 – Biosimilarity
- BLA 761497/Original 2 – Interchangeability
The FDA had issued a separate action letter for the biosimilarity portion on July 24, 2026. The September 15, 2026 action specifically covers the interchangeability determination.
Post-Approval Requirements
Following approval, the sponsor is required to submit the approved labeling in Structured Product Labeling (SPL) format through FDA’s eLIST system within 14 days. The approval letter also specifies ongoing requirements for adverse experience reporting, distribution reporting, and biological product deviation reporting.
The FDA also identified Garzulys as a Part 3 combination product, making additional postmarketing safety reporting requirements applicable under 21 CFR Part 4, Subpart B.
Intelligent Takeaway
This approval represents a significant regulatory milestone for insulin aspart biosimilar development, with the FDA action covering the interchangeability component of BLA 761497 following the earlier biosimilarity approval.
Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761497Orig2s000ltr.pdf