Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable* biosimilar to NovoLog® (Insulin Aspart). KIRSTY is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. KIRSTY will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.

The FDA approval of KIRSTY expands Biocon Biologics’ biosimilar insulin portfolio, which also includes the first approved interchangeable biosimilar, Semglee® (Insulin Glargine-yfgn Injection). KIRSTY has been available in Europe and Canada since 2022.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: “The FDA approval of Kirsty™, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the U.S., is a significant step forward in our efforts to make insulin more accessible and affordable. It builds on the foundation we laid with Semglee®, reinforcing our commitment to scientific excellence and patient-centric innovation. With Kirsty™, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care.”

There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter of them being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.¹ Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA.

Biocon Biologics is a global leader in biosimilars and insulin production and is among the top three global players for rh- Insulin and Insulin Glargine, providing over 9.2 billion doses of insulin globally with a broad portfolio comprising basal, mixed and rapid acting insulins.

The Company has achieved many “firsts” in the industry including the first to receive approval of biosimilar Trastuzumab in the United States, Ogivri®, as well as Fulphila™ (bPegfilgrastim), and Semglee® (bInsulin Glargine) in the United States. Globally, serving over 5.8M patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including eight in the United States and seven in Canada, with a robust portfolio of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas.

* An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of KIRSTY has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.