On 15 July 2025, the US Food and Drug Administration (FDA) approved Biocon Biologics’ Kirsty (insulin aspart-xjhz), a biosimilar to Novo Nordisk’s NovoLog (insulin aspart). This approval designates Kirsty as the first and only interchangeable biosimilar for a rapid-acting insulin, a significant milestone in diabetes treatment access.
The approval for Kirsty (insulin aspart-xjhz) was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Kirsty is highly similar to NovoLog. The data demonstrated that there were no clinically meaningful differences between Kirsty and NovoLog in terms of safety, efficacy, purity, and potency.
Kirsty, a 100 units/mL rapid-acting insulin, is approved to improve glycaemic control in adults and paediatric patients with type 1 and type 2 diabetes. Insulin aspart products like Kirsty and NovoLog have a faster onset and a shorter duration of activity than human insulin, making them ideal for managing blood sugar spikes around mealtimes [1].
Kirsty follows Sanofi-Aventis' Merilog (insulin aspart-szjj) that was approved for improving glycaemic control in adults and paediatric patients with diabetes mellitus and was the first rapid-acting insulin biosimilar to receive FDA authorization, with the decision announced on 14 February 2025 [2].
These rapid onset products follow the two existing long-acting insulin biosimilar products: Eli Lilly’s Rezvoglar (insulin glargine-aglr) and Mylan/Biocon’s Semglee (insulin glargine-yfgn) [3, 4]. Semglee, the first insulin biosimilar approved on 11 June 2020, also became the first to receive the interchangeable status on 28 July 2021 [5], and Rezvoglar was approved on 17 December 2021, also holds interchangeable status.
Kirsty is however the first interchangeable rapid onset insulin product. Granting the interchangeability designation permits pharmacists, in accordance with state laws, to substitute Kirsty for NovoLog without requiring approval from the prescribing physician [6].
The approval of Kirsty expands Biocon Biologics’ US biosimilar insulin portfolio, which already includes the first interchangeable biosimilar, Semglee (Insulin Glargine-yfgn) injection. Kirsty has been available in Europe and Canada since 2022.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin aspart [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-insulin-aspart
2. GaBI Online - Generics and Biosimilars Initiative. Insulin aspart and denosumab biosimilars approved in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/news/insulin-aspart-and-denosumab-biosimilars-approved-in-us
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-adalimumab-and-insulin-glargine-biosimilars-yusimry-and-rezvoglar
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. What is the future for the US biosimilar interchangeability designation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 3]. Available from:
www.gabionline.net/biosimilars/research/what-is-the-future-for-the-us-biosimilar-interchangeability-designation
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