Biocon Biologics, Civica expand partnership, launch private label Insulin Glargine to broaden US diabetes treatment options

Bengaluru: Biocon Biologics Ltd., a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has announced expansion of its strategic collaboration with Civica, Inc. to include a new Insulin Glargine medicine that will benefit patients in the United States.

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.