FDA Approves Garzulys as Third Biosimilar to NovoLog

The FDA approved Garzulys (insulin aspart-fsan) injection, a biosimilar to NovoLog (insulin aspart). Emerge Bioscience Pte Ltd holds the approved biologics license application for Garzulys, and Meitheal serves as the product's US regulatory agent and holds exclusive US commercialization rights under a license agreement with Emerge.¹

Garzulys is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus, and formulations are approved for both subcutaneous and intravenous administration.¹

“The FDA approval of Garzulys represents an important milestone in Meitheal’s continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products,” Tom Shea, chief executive officer of Meitheal, said in a news release.¹ “We are making deliberate, long-term investments in the regulatory expertise, commercial infrastructure, and strategic partnerships needed to expand patient access to high-quality biologic treatment options.”

Approval Details and Product Presentations

Garzulys is available in 2 presentations: a 10-mL multiple-dose vial and a 3-mL prefilled pen, both at a strength of 100 units/mL (U-100). Both are approved as biosimilar, not interchangeable, products.²

According to the prescribing information, Garzulys may be administered subcutaneously, by continuous subcutaneous insulin infusion (pump), or intravenously, and approval was based on data demonstrating that Garzulys is highly similar to NovoLog with no clinically meaningful differences between the 2 products.^1,3

Garzulys is the third FDA-approved biosimilar to NovoLog, following Merilog (insulin aspart-szjj), approved February 14, 2025, and Kirsty (insulin aspart-xjhz), approved July 15, 2025.²

Insulin Therapy in Diabetes Management

Insulin therapy is a central part of diabetes treatment, helping keep blood sugar under control and prevent complications by working like the insulin the body normally produces. In patients with type 1 diabetes, the pancreas stops producing insulin, so insulin therapy is required to stay healthy, and in type 2 diabetes, insulin therapy may become necessary when lifestyle changes and other diabetes medicines no longer adequately control blood sugar.⁴

Left untreated, high blood sugar can lead to serious complications over time, including heart attack or stroke, kidney failure, vision loss, and diabetic neuropathy.⁴

Rapid-acting insulins, such as insulin aspart, are designed for use around mealtimes. They begin working within 5 to 15 minutes, blunt the after-meal rise in blood sugar, and last about 2 to 3 hours, in contrast to long- and intermediate-acting insulins that keep blood sugar from rising between meals over much longer durations. Patients can take insulin by injection with a syringe or pen, by continuous infusion through an insulin pump, or, for some rapid-acting formulations, by inhalation.⁴

Because insulin regimens are individualized based on diabetes type, blood sugar patterns, and lifestyle, patients may need more than one type of insulin, and any changes to a regimen warrant close monitoring and, when needed, adjustment by the health care team.⁴

What This Means for Pharmacists

The Garzulys prescribing information carries warnings common to insulin aspart products, including hypoglycemia, hypersensitivity reactions, hypokalemia, and hyperglycemia or hypoglycemia associated with changes in insulin regimen. The label also warns against ever sharing a Garzulys prefilled pen between patients, even if the needle is changed, because of the risk of bloodborne pathogen transmission and instructs patients to always check the insulin label before each injection to avoid mix-ups between products. Common adverse reactions include hypoglycemia, allergic reactions, local injection-site reactions, lipodystrophy, rash, and pruritus.³

With Garzulys now the third NovoLog biosimilar on the market alongside Merilog and Kirsty, pharmacists filling and counseling on rapid-acting insulin aspart products have a growing number of similarly acting, similarly named options to distinguish at the point of dispensing.²

The prescribing information reiterates standard insulin counseling points relevant to pharmacy practice: rotating injection sites to reduce the risk of lipodystrophy and localized cutaneous amyloidosis, recognizing signs and symptoms of hypoglycemia, and understanding proper storage, including refrigeration until first use and a 28-day in-use limit at room temperature. As with other rapid-acting insulins, patients generally inject Garzulys within 5 to 10 minutes before a meal, and it is typically used alongside an intermediate- or long-acting insulin as part of a full regimen.^3,4

REFERENCES

1. Meitheal Pharmaceuticals, Inc. Meitheal Pharmaceuticals Announces FDA Approval of Garzulys™ (insulin aspart-fsan) Injection. News release. Meitheal Pharmaceuticals, Inc. July 30, 2026. Accessed August 3, 2026. https://www.businesswire.com/news/home/20260730232521/en/Meitheal-Pharmaceuticals-Announces-FDA-Approval-of-Garzulys-insulin-aspart-fsan-Injection

2. Drugs.com. Garzulys (insulin aspart-fsan) FDA Approval History. Drugs.com. Updated August 2, 2026. Accessed August 3, 2026. https://www.drugs.com/history/garzulys.html

3. US Food and Drug Administration. Garzulys (insulin aspart-fsan) injection, prescribing information. FDA.gov. Revised July 2026. Accessed August 3, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761497s000lbl.pdf

4. Mayo Clinic Staff. Diabetes treatment: Using insulin to manage blood sugar. Mayo Clinic. Accessed August 3, 2026. https://www.mayoclinic.org/diseases-conditions/diabetes/in-depth/diabetes-treatment/art-20044084