Biocon Biologics Ltd., a unit of India’s Biocon Ltd., has expanded its partnership with US-based nonprofit Civica Inc. to launch a private-label version of insulin glargine in the United States, aiming to widen access to affordable diabetes treatment for millions of Americans.
Under the multi-year agreement, Biocon Biologics will manufacture and supply insulin glargine to Civica, which will commercialize the product under its own label. In California, the product will be sold under the state’s CalRx brand.
Financial terms of the insulin glargine agreement were not disclosed. The deal does not involve a technology transfer, and Biocon Biologics will retain the intellectual property and marketing authorization for the drug.
The move builds on a previous collaboration between the two companies, under which Biocon Biologics supplies insulin as part of a drug substance to Civica for US manufacturing. The latest agreement is expected to bolster Civica’s mission of offering low-cost insulin to underserved populations.
“We are building on our differentiated approach to enhance patient access—by retaining our direct commercialization and through this strategic partnership,” said Shreehas Tambe, CEO and Managing Director of Biocon Biologics.
Civica CEO Ned McCoy called the deal a “significant milestone” in the nonprofit’s insulin initiative, which aims to provide transparent, low-cost insulin options to U.S. patients.
Biocon Biologics’ insulin glargine-yfgn, approved by the USFDA in July 2021 as the first interchangeable biosimilar to Sanofi’s Lantus, is indicated for improving glycemic control in adults and children with diabetes mellitus. The company will continue to market its own version of the drug alongside Civica’s private-label offering.
The US faces a growing diabetes burden, with 38.4 million people—about 11.6% of the population—living with the disease, according to the CDC. Nearly a quarter remain undiagnosed, and an additional 97.6 million Americans are prediabetic.
Biocon Biologics, the world’s fourth-largest insulin producer, has delivered over 9.2 billion doses globally and has a portfolio spanning basal, mixed, and rapid-acting insulins. The company has commercialized 10 biosimilars and is active in over 120 countries.
Civica, founded in 2018 by US health systems and philanthropies, operates a sterile injectable manufacturing facility in Virginia and is focused on addressing chronic drug shortages.
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