HQ Team
July 15, 2025: The US Food and Drug Administration has approved a biosimilar product made by India’s Biocon Biologics Ltd., a subsidiary of Biocon Ltd., to treat diabetes mellitus in adults and pediatric patients.
Kirsty is the fourth rapid-acting biosimilar product to improve glycemic control in diabetic patients and is a substitute for Novolog (insulin aspart), according to an emailed statement from the USFDA. Insulin aspart is a rapid-acting medicine that takes about 15 minutes to take effect and lasts for a shorter duration compared to insulin glargine.
The human insulin analog comes in a 3 mL (millilitre) single-patient-use prefilled pen and a 10 mL multiple-dose vial.
A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference product. Kirsty may be substituted at the pharmacy for the reference product, depending on state laws.
Individualised dosing
The Kirsty 3 mL prefilled pen is administered subcutaneously, and the Kirsty 10 mL vial is administered subcutaneously, by continuous subcutaneous infusion (insulin pump), or intravenously.
Dosing of Kirsty, like Novolog, should be individualised based on the patient’s needs and should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin aspart products.
Kirsty may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, and hypokalemia (low potassium in your blood).
The most common side effects associated with insulin aspart products other than hypoglycemia include lipodystrophy (pitting at the injection site), weight gain and allergic reactions, such as injection site reactions, rash, redness, pain and severe itching.
More treatment options
Kirsty (insulin aspart-xjhz) is the 72nd biosimilar product approved in the US, and the fourth biosimilar insulin product approved in the US, according to the US regulator.
The availability of biosimilar and interchangeable insulin products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients, it stated.
In 2022, Biocon Biologics acquired Viatris Inc.’s biosimilars business for $3.4 billion, including cash up to $2.4 billion and Compulsorily Convertible Preference Shares in Biocon Biologics, valued at $1 billion. The aim was to create a fully integrated global biosimilars enterprise.
Biocon Biologics in December 2023 stated that more than ten emerging markets, along with Japan, Australia and New Zealand, have transitioned in this final phase of the integration of the biosimilars business acquired from Viatris.
The company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.
