Biocon Biologics Ltd. and pharmaceutical nonprofit Civica, Inc. are expanding their partnership to bring a new private-label version of Insulin Glargine to the U.S. market, aiming to improve access to affordable insulin for millions of Americans living with diabetes.
Under the new multi-year agreement, Biocon Biologics will manufacture and supply Insulin Glargine to Civica, which will market and distribute it under its own label in the U.S. In California, the product will be sold under the CalRx brand as part of the state’s initiative to provide low-cost prescription drugs directly to residents.
Biocon Biologics will continue to drive its own direct commercialization of Insulin Glargine, complementing the Civica-labeled product to broaden access and ensure patients have multiple pathways to affordable insulin.
“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. “This collaboration enables us to reach underserved populations through new channels in direct alignment with our mission.”
Civica President and CEO Ned McCoy said the new arrangement furthers the company’s mission to make essential medicines more affordable. He also thanked California for being the first state to contract for affordable insulin.
“We’re pleased to expand our partnership with Biocon Biologics, which helps us achieve a significant milestone in our insulin initiative. This collaboration enables us to deliver insulin at a transparent low price to the people who need it most,” McCoy said. “We are grateful for the support of the state of California for our effort to bring affordable insulin to all Americans. The state shares our vision to ensure a sustainable, quality supply of affordable, essential medicines for people who need them.”
Gov. Gavin Newsom praised the Civica-CalRx partnership as an example of how states can take action to lower drug prices.
“California didn’t wait for the pharmaceutical industry to do the right thing — we took matters into our own hands,” he said. “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.”
Biocon Biologics’ Insulin Glargine-yfgn — the first interchangeable biosimilar insulin approved by the U.S. Food and Drug Administration in 2021 — will serve as the foundation for the Civica partnership. The medicine is indicated to improve glycemic control in adults and children with diabetes mellitus and is not recommended for the treatment of diabetic ketoacidosis.
Biocon Biologics, whose North American headquarters is in New Jersey, will retain ownership of the product’s intellectual property and marketing authorization. The company is among the world’s top insulin producers, delivering more than 9.2 billion doses annually, including basal, mixed, and rapid-acting insulins.
The collaboration comes amid widespread concern about the cost of insulin in the United States, where more than 38 million people — approximately 11.6% of the population — have diabetes, and nearly 98 million more are prediabetic.
“In a moment where inflation is spiking everyday prices for Californians and our health care system is under attack in the form of Medicaid cuts from H.R. 1, a lower cost insulin will bring much needed relief both to California pocketbooks and our state budget,” said member Chris Noble, Health Access California’s Organizing Director and member of the CalRx Insulin Patient Advisory Council. “California consumers need relief now, so as a person dependent on insulin to live and a health care advocate, I’m relieved to see CalRx moving quickly to lower insulin costs for the people of California.”
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