Biocon’s arm gets USFDA’s nod for Kirsty

Biocon Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 532523 | NSE: BIOCON

16 Jul 2025 Evaluate

Biocon’s subsidiary -- Biocon Biologics (BBL) has received approval from U.S. Food and Drug Administration (USFDA) for 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.

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. Sales of Insulin Aspart in the United States were around $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 5.8 million 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.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

Biocon Share Price

380.55 -2.05 (-0.54%)

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