Biocon Biologics and Civica Strengthen Collaboration to Launch Private-Label Insulin Glargine in the United States
Friday, October 17, 2025
Biocon Biologics has expanded its partnership with Civica, Inc. to introduce a new private-label Insulin Glargine medicine in the United States.
Insulin Glargine-yfgn injection is indicated for improving glycaemic control in adults and children with diabetes mellitus. However, it is not recommended for managing diabetic ketoacidosis.
In the United States, around 38.4 million people—approximately 11.6 per cent of the population—are living with diabetes, with nearly one-quarter of cases undiagnosed. In addition, about 97.6 million Americans are classified as prediabetic.
The initiative aims to improve access to affordable, high-quality insulin and address the growing demand for diabetes treatment options.
Under the multi-year agreement, Biocon Biologics will manufacture and supply Insulin Glargine to Civica, which will distribute, promote, and sell the product in the U.S. through an exclusive distributorship arrangement. The medicine will be marketed under a separate Civica label and trade dress, while in California it will carry the CalRx brand.
Biocon Biologics will continue to commercialise its own Insulin Glargine-yfgn, which received approval from the U.S. Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar insulin. The company will retain ownership of the intellectual property and marketing authorisation associated with Insulin Glargine. No technology transfer is included in the agreement, and further details of the terms remain confidential.
This new collaboration builds upon an earlier agreement in which Biocon Biologics agreed to supply Civica with Insulin Aspart drug substance for manufacturing in the United States.
The ongoing partnership reflects the shared commitment of both organisations to expand access to essential medicines at transparent and affordable prices.
Source: prnewswire.com
