Biocon Biologics, a subsidiary of Indian biopharmaceutical company Biocon, and US-based Civica have entered a strategic collaboration to enhance access to Insulin Aspart in the US.
Civica is a non-profit generic pharmaceutical company established by US health systems and philanthropies in 2018, to resolve ongoing drug shortages and affordability challenges.
The company has built a sterile injectable manufacturing plant in Petersburg, Virginia, capable of producing prefilled pens and vials of insulin.
The partnership aims to address affordability and availability issues, with Biocon Biologics supplying the drug substance and Civica producing the drug product at its facility in Virginia.
Civica president and CEO Ned McCoy 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 utilise our US-based manufacturing operations in Petersburg, Virginia to produce prefilled pens and vials of insulin.”
Under the agreement, Biocon Biologics will provide the insulin-aspart drug substance, and Civica will manufacture the rapid-acting insulin analogue at its Virginia plant.
The commercialisation of the medicine will follow the completion of development work and clinical trials, though no technology transfer is involved.
The collaboration complements Biocon Biologics’ own Insulin Aspart Drug Product, which is currently under review by the US Food and Drug Administration.
Biocon Biologics CEO and managing director Shreehas Tambe 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.”
Last year, Biocon Biologics announced a five-year partnership with Sandoz, providing Sandoz the exclusive rights to biosimilars to Trastuzumab and Bevacizumab in Australia.
