Insulin Aspart-xjhz Becomes First Interchangeable Biosimilar Rapid-Acting Insulin

The FDA approved insulin aspart-xjhz (Kirsty; Biocon Sdn. Bhd) as the first interchangeable biosimilar insulin product to insulin aspart (Novolog; Novo Nordisk). This marks a significant milestone in improving access to insulin therapies for patients with diabetes.

Insulin and syringe | Image Credit: © Sherry Young - stock.adobe.com

As diabetes continues to affect more than 37 million Americans, expanding access to affordable insulin remains a public health priority. The approval of insulin aspart-xjhz marks an important step in broadening patient access to high-quality, lower-cost insulin options that can be safely substituted at the pharmacy counter.¹

Insulin aspart-xjhz is a rapid-acting human insulin analog indicated to improve glycemic control in both adults and pediatric patients with diabetes mellitus. It will be available as a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial, both of which are administered subcutaneously. The vial formulation may also be used via insulin pump or intravenous infusion, offering flexibility for patients and providers.²

As a biosimilar product, insulin aspart-xjhz is shown to be highly similar to insulin aspart, with no clinically meaningful differences in safety, purity, or potency. Biosimilars offer a cost-effective alternative to brand-name biologics and must undergo rigorous testing to demonstrate similarity to their reference products. However, insulin aspart-xjhz goes a step further: it has been designated by the FDA as interchangeable, meaning that—subject to state pharmacy laws—it may be substituted at the pharmacy for Novolog without the need for a new prescription from the prescriber.²

Kirsty becomes the seventy-second biosimilar approved in the United States and the fourth biosimilar insulin to receive FDA approval. Its interchangeable designation is particularly noteworthy as it expands the potential for greater market competition, which could lead to lower treatment costs and increased access for patients who rely on insulin therapy for blood glucose management.²

Like insulin aspart, dosing of insulin aspart-xjhz should be individualized based on a patient’s metabolic needs, blood glucose monitoring, and glycemic control goals. It should not be used during episodes of hypoglycemia or in individuals with known hypersensitivity to insulin aspart. Potential serious side effects include hypoglycemia, hypokalemia, and severe allergic reactions. Common side effects may include lipodystrophy, weight gain, and injection site reactions such as pain, redness, or itching.²

For patients, providers, and pharmacists, the arrival of insulin aspart-xjhz signals a growing shift toward affordable biologics and a more competitive insulin marketplace.

REFERENCES

1. National diabetes statistics report. CDC. May 15, 2024. Accessed July 15, 2025. https://www.cdc.gov/diabetes/php/data-research/index.html?utm_source=chatgpt.com

2. FDA approves first interchangeable biosimilar insulin product to Novolog (insulin aspart). FDA. July 15, 2025. Accessed July 15, 2025. app.later.com/5PWCX/linkinbio/pharmacytimes/?feedType=igFeed&tab=blocks