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Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon announced that US FDA has approved Kirsty (insulin aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog.
Kirsty is a rapid-acting human insulin analog indicated to improve glycaemic control in adults and paediatric 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, said: “The FDA approval of Kirsty, 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 diabetics in the US, approximately 11.6 per cent of the total population, with nearly a quarter being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic. Sales of insulin aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA.
The Bengaluru-based 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 US. Globally, serving over 5.8 million patients annually, it has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including eight in US and seven in Canada, with a robust portfolio of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas.
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