Meitheal Pharmaceuticals Inc (Meitheal), a fully integrated biopharma company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines, biologics, fertility products and branded medicines, announced that the US FDA has approved Garzulys (insulin aspart-fsan) injection, a biosimilar to NovoLog (insulin aspart).
Emerge Bioscience Pte. Ltd. (Emerge) is the holder of the approved Biologics License Application (BLA) for Garzulys. Meitheal serves as the product’s US Regulatory Agent and holds exclusive US commercialization rights under its license agreement with Emerge.
Garzulys is a rapid-acting human insulin analog indicated to improve glycaemic control in adults and paediatric patients with diabetes mellitus. Garzulys formulations are approved for both subcutaneous and intravenous administration.
Garzulys was developed through a collaboration between Tonghua Dongbao Pharmaceutical Co Ltd (Tonghua Dongbao) and companies affiliated with Meitheal. Tonghua Dongbao was responsible for drug substance development, Nanjing King-Friend Biochemical Pharmaceutical Co Ltd (NKF) was responsible for drug product development, Xentria, Inc. (Xentria) led the clinical development program, and Meitheal, serving as the US Regulatory Agent, led the US regulatory work supporting US FDA approval.
Emerge is the BLA holder and is responsible for key supply-chain activities associated with the product.
The collaboration initiated in 2023 between Tonghua Dongbao and NKF encompasses Garzulys and two additional insulin biosimilar candidates currently in development. Through its exclusive license agreement with Emerge, Meitheal holds exclusive US commercialization rights for Garzulys and the two additional product candidates.
“The US 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,” said Tom Shea, CEO of Meitheal. “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. Our leadership of the US regulatory process for Garzulys demonstrates the strength of our platform and the disciplined execution we bring to complex products and global partnerships.”
This approval further expands Meitheal’s presence in diabetes care and advances the company’s strategy to build a broader portfolio of biologics and branded products. Since its founding in 2017, Meitheal has developed a diversified US platform supporting more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anaesthesia, diabetes, critical care and fertility.
Warnings and precautions: Never share a Garzulys prefilled pen between patients, even if the needle is changed. Patients using Garzulys vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Hyperglycemia or Hypoglycemia with changes in insulin regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycaemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
Hypoglycemia is the most common adverse effect of all insulins, including insulin aspart products. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia.
The risk of hypoglycemia: After an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Garzulys may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to concomitantly administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Patients and caregivers must be educated to recognize and manage hypoglycemia.
Hypoglycemia due to medication errors: To avoid medication errors and accidental mix-ups between Garzulys and other insulin products, instruct patients to always check the insulin label before injection.
Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including Garzulys.
Hypokalemia: All insulins, including Garzulys, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).
Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Garzulys. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
Hyperglycemia and Ketoacidosis due to insulin pump device malfunction: Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure. |