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FDA Approves First Interchangeable NovoLog® (insulin aspart): Biocon’s Kirsty™

by Robert S. Schwartz, Ph.D.
July 23, 2025

On July 15, 2025, the FDA approved Biocon’s Kirsty™ (insulin aspart-xjhz) as the first interchangeable biosimilar of Novo Nordisk’s NovoLog® (insulin aspart).  Biocon’s aBLA for Kirsty™ (formerly MYL-1601D) was pending since July 2020 and received Complete Response Letters in January 2022 and October 2023.  Insulin aspart is a rapid acting human insulin analog that is FDA-approved to improve glycemic control in adults and pediatric patients with diabetes mellitus.

The first insulin aspart biosimilar, Sanofi’s Merilog™ / Merilog SoloStar® (insulin aspart-szjj), was approved in February 2025 (previously reported FDA Approves First NovoLog® (insulin aspart) Biosimilar: Sanofi’s Merilog™ / Merilog SoloStar®).  Sandoz / Gan & Lee have a pending aBLA at the FDA for Rapilin™ (insulin aspart), accepted in June 2023.  There are currently no related patent proceedings.

Novo Nordisk reported U.S. sales of approximately $1.06B USD (7.56B DKK) for NovoLog® (also referred to as NovoRapid®) in 2024.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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