Biocon Biologics expands partnership with Civica to launch Insulin Glargine in the US

Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, announced an expansion of its strategic collaboration with Civica, Inc. to include a new Insulin Glargine medicine aimed at increasing supply of affordable insulin for patients in the United States.

The multi-year agreement establishes an exclusive distributorship where Biocon Biologics will manufacture and supply Insulin Glargine to Civica, which will commercialise the medicine under Biocon Biologics’ existing marketing approval through a private label arrangement. Civica will distribute, promote, and sell the medicine in the US under a separate Civica label, with the product in California carrying the CalRx brand. Biocon Biologics will continue to directly commercialise its own Insulin Glargine-yfgn medicine, approved by the US Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, 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 retain ownership of the intellectual property and marketing authorisation associated with Insulin Glargine. Additional terms of the agreement were not disclosed.

The collaboration builds on a previous arrangement in which Biocon Biologics provided Civica with Insulin Aspart drug substance for manufacturing in the United States.

Ned McCoy, President and CEO, 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 paediatric patients with diabetes mellitus. It 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 undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.

Biocon Biologics is the fourth largest insulin company globally, providing over 9.2 billion doses of insulin with a portfolio comprising basal, mixed, and rapid-acting insulins.

Important Safety Information:

Insulin Glargine-yfgn is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or any of its excipients.

Warnings and precautions include: never sharing insulin pens, needles, or syringes; monitoring blood glucose levels during regimen changes; rotating injection sites to avoid lipodystrophy or cutaneous amyloidosis; and monitoring for hypoglycemia, severe allergic reactions, and hypokalemia. Fluid retention may occur with concomitant use of thiazolidinediones, and dosage adjustments may be needed for patients with renal or hepatic impairment. Insulin Glargine-yfgn must not be diluted, mixed with other insulins, or administered via pump or intravenously.