Biocon Biologics and Civica, Inc. have announced a strategic partnership aimed at expanding access to affordable Insulin Aspart across the United States, addressing a critical need in diabetes care management.
Under the newly formed agreement, Biocon Biologics will provide Insulin Aspart drug substance to Civica, which will then manufacture the final rapid-acting insulin analog product at its Petersburg, Virginia facility. The partnership does not involve any technology transfer between the companies.
The collaboration comes at a crucial time, as diabetes continues to pose a significant public health challenge in the United States. Current statistics reveal that 38.4 million Americans—approximately 11.6% of the population—live with diabetes, with nearly a quarter remaining undiagnosed. An additional 97.6 million Americans are classified as prediabetic, highlighting the potential for growing insulin demand.
Manufacturing and Distribution Strategy
Civica will handle the downstream processing and commercialization of the insulin product, focusing on producing both prefilled pens and vials at their U.S.-based manufacturing facility. This domestic production capability is expected to strengthen the supply chain and ensure consistent availability of the medication.
Addressing Affordability Challenges
The partnership specifically targets the pressing issue of insulin affordability. According to Civica's findings, one in five diabetes patients has been forced to ration their insulin usage due to financial constraints, either by skipping doses, delaying treatment, or using less than the prescribed amount.
"Our collaboration with Civica reflects our commitment to expanding patient access to Insulin Aspart in the United States while reinforcing our dedication to serving the growing needs of people living with diabetes," stated Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd.
Dual Market Approach
Notably, this partnership operates independently of Biocon Biologics' own Insulin Aspart Drug Product, which is currently under review by the U.S. Food and Drug Administration (FDA). This dual approach demonstrates the company's comprehensive strategy to increase insulin accessibility in the U.S. market.
Ned McCoy, President and CEO of Civica, Inc., emphasized the organization's mission: "Civica's mission is to help people who need access to necessary generic and biosimilar medicines at affordable prices. Our partnership with Biocon Biologics for Aspart drug substance supply will allow us to deliver on our important mission."
