Biocon Biologics Ltd., a fully integrated global biosimilars company, announced the expansion of its strategic collaboration with nonprofit pharmaceutical company Civica, Inc. to include a new insulin glargine medicine that will increase access to affordable diabetes treatments for patients in the United States.
The multi-year agreement creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply insulin glargine medicine to Civica, which will commercialize the product under Biocon Biologics' existing FDA marketing approval through a private label agreement. Civica will distribute, promote, and sell the medicine under a separate Civica label and trade dress, while in California, the product will carry the CalRx brand.
Partnership Details and Market Impact
The collaboration addresses the needs of 38.4 million people with diabetes in the United States, representing 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, according to CDC data.
"Biocon Biologics is committed to expanding access to affordable, high-quality insulins in the U.S. and globally," said Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd. "By extending our collaboration with Civica, Inc. to include Insulin Glargine, we are building on our differentiated approach to serving and enhancing patient access—by retaining our direct commercialization and through this strategic partnership."
Biocon Biologics will continue to directly commercialize its own insulin glargine-yfgn medicine, which was approved by the U.S. Food and Drug Administration in July 2021 as the first interchangeable biosimilar. No technology transfer is involved in the agreement, and Biocon Biologics will retain ownership of the intellectual property and marketing authorization associated with insulin glargine.
Expanding Access Through Strategic Distribution
Ned McCoy, President and Chief Executive Officer of Civica, Inc., emphasized the significance of the partnership: "We are pleased to expand our partnership with Biocon Biologics, which helps us achieve a significant milestone in our insulin initiative. Today's announcement allows us to realize our goal of bringing insulin to people who need it at a transparent low price."
This agreement builds upon the existing relationship between the two organizations, which previously announced that Biocon Biologics would provide Civica with insulin aspart drug substance for manufacturing in the United States. The expanded partnership enables both companies to reach underserved populations through new distribution channels.
Clinical Profile and Safety Information
Insulin glargine-yfgn injection is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus, with limitations noting it is not recommended for the treatment of diabetic ketoacidosis. The medication carries important safety considerations, including contraindications during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine products.
Key safety warnings include the need for careful blood glucose monitoring, proper injection site rotation to prevent lipodystrophy, and awareness of hypoglycemia as the most common adverse reaction. The medication should not be diluted or mixed with other insulins and requires specific administration protocols to ensure patient safety.
Market Position and Global Reach
Biocon Biologics positions itself as a global leader in biosimilars and insulin production, ranking as the fourth largest insulins company worldwide. The company provides over 9.2 billion doses of insulin globally through a broad portfolio comprising basal, mixed, and rapid-acting insulins, serving over 6.0 million patients across more than 120 countries.
Civica, founded in 2018 as a nonprofit generic pharmaceutical company, was established to address drug shortages and has built a sterile injectable manufacturing plant in Petersburg, Virginia capable of producing prefilled pens and vials of insulin. The organization serves over 1,400 hospitals with more than 70 essential medicines, supporting care for over 90 million patients through its 60 members, including leading health systems, hospitals, and philanthropic organizations.
