Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty

Business Standard

2 days ago

Bengaluru-based Biocon's subsidiary, Biocon Biologics Limited (BBL), announced today that the US 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 analogue indicated for improving glycaemic control in adults and paediatric patients with diabetes mellitus. It will be available as a single-patient-use prefilled pen for subcutaneous administration and as a multi-dose vial for both subcutaneous and intravenous use.
Shreehas Tambe, Chief Executive Officer and Managing Director, BBL, said: 'The FDA approval of Kirsty, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the US, 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.'
The FDA approval of Kirsty further strengthens Biocon Biologics' biosimilar insulin portfolio, which also includes Semglee Insulin, the first FDA-approved interchangeable biosimilar. Kirsty has been available in Europe and Canada since 2022.
In March, Biocon Biologics announced a strategic collaboration with Civica, Inc. to improve access and affordability of Insulin Aspart in the United States. The company has also previously received US FDA approvals for several biosimilars, including Ogivri (biosimilar Trastuzumab), Fulphila (biosimilar Pegfilgrastim), and Semglee (biosimilar Insulin Glargine).
Biocon Biologics supplies recombinant human insulin and Insulin Glargine, providing over 9.2 billion doses of insulin globally with a broad portfolio comprising basal, mixed and rapid-acting insulins. Globally, Biocon Biologics serves over 5.8 million patients annually and offers a comprehensive portfolio of approved and pipeline biosimilars across multiple therapeutic areas. This includes eight biosimilars in the United States and seven in Canada, with a robust pipeline of 20 biosimilar assets, encompassing insulins and monoclonal antibodies.
An estimated 38.4 million people in the United States — approximately 11.6 per cent of the population — are living with diabetes, with nearly a quarter remaining undiagnosed. Additionally, 97.6 million Americans have been identified as prediabetic. According to IQVIA, US sales of Insulin Aspart reached approximately $1.9 billion in 2024.