Biocon Biologics and Civica expand partnership to launch private-label Insulin Glargine in the U.S.

New Delhi: Biocon Biologics has announced expansion of its strategic collaboration with Civica, Inc. (Civica) to include a new Insulin Glargine medicine that will benefit patients in the United States by increasing supply of high-quality affordable insulins.

The multi-year transformational agreement between Biocon Biologics and Civica creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply Insulin Glargine medicine to Civica, and Civica will commercialize under Biocon Biologics’ existing marketing approval (a private label agreement). Civica will distribute, promote, and sell the medicine in the United States under a separate Civica label and trade dress, and in California, the product will carry the CalRx brand. Biocon Biologics will continue to directly commercialize Biocon Biologics’ own Insulin Glargine-yfgn medicine, which was approved by the U.S. Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: “Biocon Biologics is committed to expanding access to affordable, high-quality insulins in the U.S. and globally. 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. This collaboration enables us to reach underserved populations through new channels in direct alignment with our mission.”

No technology transfer is involved in the agreement and Biocon Biologics will continue to own the intellectual property and marketing authorization associated with Insulin Glargine. Additional terms of the agreement are not disclosed.

This agreement expands the relationship between the two organizations that previously announced that Biocon Biologics will provide Civica with Insulin Aspart drug substance to manufacture in the United States.

Ned McCoy, President and Chief Executive Officer, Civica, Inc., said: “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.”

Insulin glargine-yfgn injection is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of use: Insulin glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.

There are 38.4 million people with diabetes in the United States, 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.¹ 

Biocon Biologics is a global leader in biosimilars and insulin production and is the fourth largest insulins company in the world, providing over 9.2 billion doses of insulin globally with a broad portfolio comprising basal, mixed and rapid acting insulins.