Strategic collaboration aims to make life-saving insulin more accessible to 38.4 million Americans living with diabetes.
NFAPost, Bengaluru: In a significant move toward improving access to affordable diabetes care in the United States, Biocon Biologics Ltd. (BBL), a global biosimilars leader and subsidiary of Biocon Ltd., announced the expansion of its partnership with Civica, Inc., a U.S.-based non-profit pharmaceutical company. The collaboration introduces a new private-label Insulin Glargine that will broaden treatment options for millions of Americans managing diabetes.
Under this multi-year agreement, Biocon Biologics will manufacture and supply Insulin Glargine, while Civica will commercialize the medicine in the U.S. under its own label and trade dress. In California, the product will also be available under the CalRx brand. The arrangement allows Civica to distribute the insulin through its established network, leveraging Biocon Biologics’ existing FDA-approved marketing authorization.
“Biocon Biologics is committed to expanding access to affordable, high-quality insulins in the U.S. and globally,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. “By extending our collaboration with Civica to include Insulin Glargine, we are building on our differentiated approach to patient access—through both our direct commercialization and this strategic partnership. This collaboration enables us to reach underserved populations through new channels in direct alignment with our mission.”
Importantly, the agreement does not involve any technology transfer, ensuring Biocon Biologics retains ownership of the intellectual property and marketing authorization associated with the Insulin Glargine product. Specific financial terms of the deal remain undisclosed.
This expanded collaboration builds upon the companies’ earlier partnership, in which Biocon Biologics agreed to provide Insulin Aspart drug substance to Civica for U.S. manufacturing.
Ned McCoy, President and CEO of Civica, emphasized the partnership’s significance in addressing the affordability crisis in diabetes care.
“We are pleased to expand our partnership with Biocon Biologics, which helps us achieve a significant milestone in our insulin initiative,” McCoy said. “Today’s announcement allows us to realize our goal of bringing insulin to people who need it at a transparent low price.”
Addressing a National Health Challenge
According to the Centers for Disease Control and Prevention (CDC), 38.4 million Americans—about 11.6% of the U.S. population—live with diabetes, with nearly a quarter remaining undiagnosed. An additional 97.6 million adultsare considered prediabetic, underscoring the urgent need for affordable and reliable insulin options.
Insulin glargine-yfgn injection, the biosimilar formulation being introduced, is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. It was first approved by the U.S. Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar of its kind.
A Global Leader in Affordable Biologics
Biocon Biologics has emerged as the fourth-largest insulin producer in the world, supplying over 9.2 billion doses globally across a broad portfolio of basal, mixed, and rapid-acting insulins. The company currently serves over six million patients in more than 120 countries, leveraging cutting-edge manufacturing and research capabilities to deliver high-quality, cost-effective biosimilars.
Its commercial portfolio now includes 10 approved biosimilars, addressing chronic diseases such as diabetes, cancer, and autoimmune disorders. The company’s ongoing R&D pipeline includes 20 additional biosimilar assets, covering therapeutic areas like oncology, immunology, ophthalmology, and bone health.
The company’s ESG (Environmental, Social, and Governance) initiatives have also drawn global recognition, with Biocon Biologics being featured in the S&P Global Sustainability Yearbook 2025 for its contributions to health equity and sustainable development.
About the Partners
Biocon Biologics Limited is a subsidiary of Biocon Limited (BSE: 532523 | NSE: BIOCON), a publicly listed innovation-led biopharmaceutical company headquartered in Bengaluru, India. Founded with the mission to “transform healthcare and transform lives,” Biocon Biologics combines scientific innovation with scalable manufacturing to make advanced biologics accessible globally.
Civica, Inc., established in 2018, is a non-profit generic pharmaceutical organization created by a consortium of U.S. health systems and philanthropies. With a mandate to tackle chronic drug shortages, Civica has built a sterile injectable manufacturing plant in Petersburg, Virginia, capable of producing prefilled insulin pens and vials.
As Biocon Biologics and Civica continue to deepen their collaboration, their shared goal remains clear: to democratize access to insulin and redefine affordability in the U.S. diabetes care landscape.
For more information:
Civica, Inc.: www.civicarx.org | X: @CivicaRx | LinkedIn: CivicaRx
Biocon Biologics: www.bioconbiologics.com | X: @BioconBiologics | LinkedIn: Biocon Biologics
