Biocon Biologics And Civica Team To Launch Private-Label Insulin Glargine In The U.S.
In a move aimed at expanding affordable treatment options for millions of Americans living with diabetes, Biocon Biologics Ltd. and nonprofit generic drug manufacturer Civica, Inc. have announced a new agreement to launch a private-label version of Insulin Glargine in the United States.
Under the multi-year partnership, Biocon Biologics will manufacture and supply the long-acting insulin for Civica, which will handle distribution, marketing and commercialization in the U.S. under its own label— and under the CalRx brand in California. The collaboration is designed to increase access to high-quality, low-cost insulins while Biocon Biologics. Biocon Biologics will continue its own direct commercialization of Insulin Glargine, complementing the Civica-labeled product to broaden access and provide patients with multiple pathways to affordable insulin. The company’s Insulin Glargine-yfgn medicine was approved by the U.S. Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar.
Biologics is the fourth largest insulin company in the world delivering more than 9.2 billion doses of insulin globally each year, including basal, mixed, and rapid-acting insulins. The new glargine-yfgn injection is for improving glycemic control in adults and children with diabetes mellitus, and is not recommended for the treatment of diabetic ketoacidosis.
“Biocon Biologics is committed to expanding access to affordable, high-quality insulins in the U.S. and globally,” said Shreehas Tambe, CEO and managing director of Biocon Biologics. “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.”
The agreement builds on an existing partnership between the two companies, under which Biocon Biologics supplies Civica with Insulin Aspart drug substance for domestic manufacturing.
Civica President and CEO Ned McCoy called the expansion “a significant milestone” in the company’s insulin affordability initiative, which “allows us to realize our goal of bringing insulin to people who need it at a transparent low price.”
The collaboration comes amid growing pressure to address the cost of insulin in the U.S., where 38.4 million people — roughly 11.6% of the population — have diabetes, and an estimated 97.6 million more are prediabetic. In California, where Civica will distribute the product under the CalRx brand, Gov. Gavin Newsom hailed the move as a landmark step toward making insulin affordable statewide.
“California didn’t wait for the pharmaceutical industry to do the right thing — we took matters into our own hands,” Newsom said in a statement. “By beginning the process to manufacture our own insulin and pricing it at a maximum cost of $11 a pen in a five-pack, California and Civica are showing the nation what it looks like to put people over profits. No Californian should ever have to ration insulin or go into debt to stay alive — and I won’t stop until health care costs are crushed for everyone.”
This story was originally published October 30, 2025 at 8:48 AM with the headline "Biocon Biologics And Civica Team To Launch Private-Label Insulin Glargine In The U.S.."
