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Biocon Biologics, a global leader in biosimilars and the world’s fourth-largest insulin producer, has announced the expansion of its strategic partnership with Civica, Inc., a US-based non-profit pharmaceutical company to include a new insulin glargine medicine that will benefit patients in the United States by increasing supply of high-quality affordable insulins.
This partnership builds on the existing collaboration for Insulin Aspart and marks a significant milestone in Biocon Biologics’ mission to expand access to high-quality, affordable insulins for the 38.4 million Americans living with diabetes.
Bengaluru-based Biocon Biologics will manufacture and supply insulin glargine to Civica, which will commercialize it in the US under a private label using Biocon Biologics’ existing FDA marketing approval. In California, the product will be distributed under the CalRx brand. The company will also continue to directly commercialize its own FDA-approved interchangeable biosimilar, Insulin Glargine-yfgn. There is no technology transfer is involved and Biocon Biologics retains all intellectual property and marketing authorization. The partnership aims to increase the supply of affordable insulins and reach underserved populations through new distribution channels.
Shreehas Tambe, CEO & managing director, Biocon Biologics stated, “We are committed to expanding access to affordable, high-quality insulins in the US 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.”
In 2000, India was at the epicenter of the diabetes epidemic, however many patients could not afford life-saving insulins. This is what prompted scientists at Biocon Biologics to leverage their understanding of recombinant technologies to start a human recombinant insulin development program to make a difference to patients not just in India, but across the world.
Looking ahead, Biocon Biologics remains committed to the therapeutic area of diabetes. The company plans to continue with the expansion of our unique insulin portfolio, increase affordability and access while maintaining our cutting-edge manufacturing processes.
The new agreement with Civica for Insulin Glargine expands upon the existing partnership for Insulin Aspart, further strengthening Biocon Biologics’ presence in the US diabetes care market. Biocon Biologics will continue to directly commercialize Insulin Glargine-yfgn, which the FDA approved in July 2021 as the first interchangeable biosimilar Insulin Glargine, while also manufacturing and supplying insulin glargine to Civica for its private-label US launch (including CalRx in California).
The collaboration expands Biocon Biologics’ insulin business and is a key part of its growth strategy. With its vertically integrated model, Biocon Biologics is among the few companies positioned to operate as both a contract manufacturer and a commercial player, creating multiple revenue opportunities.
There are 38.4 million people with diabetes in the US, with nearly a quarter undiagnosed and an additional 97.6 million prediabetic. The US diabetes market continues to grow, and Biocon Biologics’ expanded partnership with Civica is positioned to address both access and affordability challenges, said the communication note from the company.
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