Biocon Biologics has announced expansion of its collaboration with Civica to include a new Insulin Glargine medicine that will benefit patients in the United States (US) 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 commercialise under Biocon Biologics’ existing marketing approval. Civica will distribute, promote and sell the medicine in the US under a separate Civica label and trade dress, and in California, the product will carry the CalRx brand. Biocon Biologics will continue to directly commercialise Biocon Biologics’s own Insulin Glargine-yfgn medicine, which was approved by the US Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar.

Shreehas Tambe, Chief Executive Officer (CEO) and Managing Director (MD), Biocon Biologics, said, “Biocon Biologics is committed to expanding access to affordable, high-quality insulins in the US 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 commercialisation 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 authorisation associated with Insulin Glargine. Additional terms of the agreement are not disclosed.

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

Ned McCoy, President and Chief Executive Officer, Civica, 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 realise 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 paediatric patients with diabetes mellitus.

There are 38.4 million people with diabetes in the US, 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.