Kirsty, Biocon’s Insulin Aspart, Becomes First Interchangeable NovoLog Biosimilar in the US

The FDA has approved Kirsty (insulin aspart-xjhz), developed by Biocon Biologics Ltd, as the first and only interchangeable biosimilar to NovoLog (insulin aspart) in the US. Kirsty improves blood sugar control in adults and children with diabetes mellitus.

The drug’s interchangeable status could improve insulin affordability and access by enabling pharmacy-level substitution, potentially lowering costs and simplifying treatment.

Kirsty is a rapid-acting insulin aspart biosimilar — a fast-acting form of insulin that helps control blood sugar spikes after meals. Being the first interchangeable biosimilar of its kind in the US, it would allow pharmacists to substitute it for NovoLog without needing a new prescription. This designation required evidence that Kirsty has the same clinical effect and safety profile as the reference product, even when patients alternate between the two.

The NovoLog biosimilar is supplied as 100 units per mL insulin, available in a single-use prefilled pen for subcutaneous injection and a multiple-dose vial for subcutaneous or intravenous use.

Diabetes affects about 38.4 million Americans — 11.6% of the US population — with many unaware of their condition. Another 97.6 million have prediabetes, placing them at higher risk. Managing blood sugar is crucial to reducing complications like heart disease, kidney failure and nerve damage.

Biocon Biologics, a subsidiary of Biocon Limited, is a global biosimilars company with a broad insulin portfolio. It has delivered billions of insulin doses worldwide and holds approvals for several biosimilars, including trastuzumab and the interchangeable insulin glargine product Semglee. Kirsty has been available in Europe and Canada since 2022, and its US approval expands Biocon’s presence in the insulin market.

Important safety information includes that Kirsty is contraindicated during hypoglycemia and in patients allergic to insulin aspart or its ingredients. Other warnings cover severe allergic reactions, low potassium and fluid retention with certain medications.

Biocon Biologics plans to use this approval to expand its diabetes portfolio and improve global access to biosimilar insulins.

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What’s Happening in the Biosimilars Space Recently?

The biosimilars market is growing steadily, with reports projecting a compound annual growth rate (CAGR) of 19.4% through 2030. This growth reflects rising adoption of biosimilar therapies, changing regulatory environments and manufacturers’ efforts to make biologic drugs more affordable worldwide.

To meet increasing demand, companies are expanding manufacturing capacities steadily. Alvotech recently acquired new assembly and packaging facilities to boost capacity. Sandoz is investing in a new manufacturing plant in Slovenia to better serve the European market. Amphastar Pharma plans to significantly increase its domestic manufacturing capacity in California by 2027 to support the availability of biosimilars and generic injectables in the US.

Meanwhile, India-based Wockhardt is exiting its loss-making US generics business to improve margins and focus on biosimilars and innovative therapies, including insulin-based treatments for diabetes.

While there is significant positive momentum in the biosimilars space, some areas call for caution. A recent report highlighted concerns that Medicare drug price negotiations could introduce uncertainty for biosimilar manufacturers, potentially delaying competition and limiting cost savings. The analysis estimates that lost savings from delayed biosimilar entry could total more than half of a reference biologic’s annual sales.

Although further policy refinements may be needed, biosimilars continue to play an important role in expanding patient access and affordability today.

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