Latest news with #InsulinGlargine
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Business Standard
16-07-2025
- Business
- Business Standard
Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty
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.
BusinessToday
30-06-2025
- Health
- BusinessToday
Biocon Surpasses 100 Million Insulin Cartridges Supplied To MOH
Biocon Biologics Ltd's Malaysian arm, Biocon Sdn Bhd has crossed a major milestone by supplying over 100 million cartridges of recombinant human insulin (rh-insulin) to Malaysia's Ministry of Health since 2016, benefitting more than 345,000 diabetes patients nationwide. The insulin is produced at Biocon's state-of-the-art manufacturing facility in Johor, established with a cumulative investment of US$600 million. Recognised by the Malaysia Book of Records as the first and largest integrated insulin manufacturer in the country, the plant produces a wide range of insulins in various delivery forms. 'Every cartridge we produce at our state-of-the-art facility in Johor is a lifeline for someone living with diabetes,' said Biocon Biologics Chief Commercial Officer Susheel Umesh. Biocon Biologics' longstanding partnership with the Ministry of Health and Duopharma Marketing Sdn. Bhd. aims to advance insulin access and healthcare resilience. Leonard Ariff Abdul Shatar, Group Managing Director of Duopharma Biotech Berhad, reaffirmed this, stating the collaboration is focused on delivering affordable, high-quality insulin to Malaysians. Globally, Biocon Biologics is ranked among the top three producers of rh-insulin and Insulin Glargine, having delivered 9.2 billion doses to date. Related
Business Upturn
30-06-2025
- Business
- Business Upturn
Biocon Biologics crosses 100 million insulin cartridge deliveries in Malaysia
By Aman Shukla Published on June 30, 2025, 08:56 IST Biocon Biologics Ltd. (BBL), through its Malaysian arm Biocon Sdn. Bhd., has delivered over 100 million cartridges of recombinant human insulin (rh-insulin) to Malaysia's Ministry of Health (MoH). The company has been supplying insulin to Malaysia since 2016, supporting diabetes management efforts across the country. As part of a long-standing public-private partnership with the Malaysian government, Biocon Biologics has helped serve around 345,000 patients by making rh-insulin more accessible. The collaboration is aimed at supporting local healthcare needs through stable supply and improved access to affordable insulin therapy. The company's insulin manufacturing facility in Johor, established with a cumulative investment of $600 million since 2011, functions as a Center of Excellence (CoE) for insulin production. The facility is equipped to manufacture various types of insulin—regular, basal, and rapid-acting—in formats such as cartridges and delivery devices. The site has been acknowledged by the Malaysia Book of Records as the country's first and largest integrated insulin manufacturer. Globally, Biocon Biologics has distributed over 9.2 billion doses of rh-Insulin and Insulin Glargine to patients, as part of its wider effort to support insulin access worldwide. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
