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.
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.
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.
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