Insulin aspart biosimilar(Biocon Ltd.)

BRIDGEWATER, N.J. and PETERSBURG, Va. and BENGALURU, India, March 6, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), and Civica, Inc. (Civica), a not-for-profit generic drug and pharmaceutical company founded in 2018 to address and resolve life-saving drug shortages and affordability, today announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the United States. Continue Reading Under the terms of the agreement, Biocon Biologics will supply Insulin Aspart drug substance to Civica, Inc., who will use the drug substance to produce Insulin Aspart drug product, a rapid-acting insulin analog, at its manufacturing facility in Petersburg, Virginia. Civica will commercialize the medicine for patients in the United States, after completion of development work and clinical trials. No technology transfer is involved in the agreement. Biocon Biologics and Civica announce agreement to expand access and affordability of Insulin Aspart in the U.S. Post this Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "As a fully integrated global biologics company, Biocon Biologics is uniquely positioned to drive commercial success through tailored go-to-market strategies that create lasting value for all stakeholders. Our collaboration with Civica reflects this commitment, enabling us to expand patient access to Insulin Aspart in the United States while reinforcing our dedication to serving the growing needs of people living with diabetes. Together, we are working to ensure more patients have access to high-quality, affordable insulin." Ned McCoy, President and Chief Executive Officer, Civica, Inc., said: "Civica's mission is to help people who need access to necessary generic and biosimilar medicines at affordable prices. This includes people living with diabetes, one in five of whom have skipped, delayed, or used less insulin than was needed to save money. Our partnership with Biocon Biologics for Aspart drug substance supply will allow us to deliver on our important mission and help people who need access to Insulin Aspart. Civica will utilize our U.S.-based manufacturing operations in Petersburg, Virginia to produce prefilled pens and vials of insulin." This collaboration is in addition to Biocon Biologics' own Insulin Aspart Drug Product for the United States which is currently under U.S. Food and Drug Administration (FDA) review. There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.1 1 U.S. Department of Health & Human Services, Centers for Disease Control and Prevention. "National Diabetes Statistics Report." Accessed: January 28, 2025. Last Reviewed: May 15, 2024. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. About Civica, Inc.: Civica is a non-profit generic pharmaceutical company established in 2018 to address drug shortages. It was founded by a group of U.S. health systems and philanthropies who, after more than a decade of chronic shortages, recognized that the market was not self-correcting and that a different approach is required. Civica works to deliver a safe, stable, and affordable supply of essential medicines to U.S. patients. Civica has built a sterile injectable manufacturing plant in Petersburg, Virginia capable of producing prefilled pens and vials of insulin. Website: Follow us on X (formerly Twitter) @civicarx and LinkedIn: CivicaRx for company updates Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd. 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