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Biocon Biologics, a subsidiary of Biocon, announced expansion of its strategic collaboration with Civica, Inc. (Civica) to include a new Insulin Glargine medicine that will benefit patients in the United States by increasing supply of high-quality affordable insulins.
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.
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.
The site recently underwent a good manufacturing practice (GMP) inspection by the US Food and Drug Administration (USFDA), which concluded with a single observation. The company said it will address the observation within the stipulated timeline and confirmed that it is not expected to impact ongoing business operations.
Biocon said the Cranbury facility represents a strategic advancement of its operations in the United States, enabling faster access to the company’s vertically integrated portfolio of products, benefiting patients in the region. With some products already commissioned from this site and additional launches in the pipeline, the facility is expected to play a key role in furthering Biocon’s mission to expand access to high-quality, affordable therapies worldwide.
Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.
In its latest financial results, Biocon reported a 95.2% decline in consolidated net profit to Rs 31.40 crore despite a 15.8% jump in net sales to Rs 3,910.10 crore in Q1 FY26 compared to Q1 FY25.
The scrip rose 0.04% to currently trade at Rs 352.90 on the BSE.
Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.
Biocon Pharma is a wholly owned subsidiary of Biocon.
The scrip rose 0.72% to currently trade at Rs 349.75 on the BSE.