Biocon Biologics Gains Edge with FDA Nod for Kirsty Insulin

Biocon Biologics has announced US FDA approval for Kirsty (Insulin Aspart-xjhz, 100 units/mL). It's an extremely important development as Kirsty is the first and only interchangeable biosimilar to NovoLog, a rapid-acting insulin brand.

Not only does this approval further solidify the company's diabetes treatment pipeline, but it also opens access to a multi-billion-dollar market—the world of rapid-acting insulins, which continues to dominate the space worth USD 1.9 billion.

Kirsty's approval will provide a less-costly option to the estimated 38.4 million Americans living with diabetes. The interchangeable label released with the FDA approval allows pharmacists to prescribe Kirsty instead of NovoLog without the need for approval from a prescriber, which is likely to decrease costs for consumers while expanding access across healthcare system.

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Kirsty will be marketed in both prefilled pens and multi-dose vials for both subcutaneous and intravenous use. It was already launched in Europe and Canada in 2022. The U.S. launch and approval for Kirsty is another indication of Biocon Biologics growing global footprint. This is Biocon Biologics' second interchangeable biosimilar that was approved by the FDA (following Semglee [Insulin Glargine-yfgn]), which sets up Biocon Biologics as an industry leader in high-cost biosimilar insulins.