Biocon Biologics and Civica expand US insulin glargine partnership

Biocon Biologics Ltd. (BBL) and Civica, Inc. announced an expanded strategic collaboration to introduce a new Insulin Glargine medicine in the United States. This multi-year agreement establishes an exclusive distributorship, with Biocon Biologics manufacturing and supplying the medicine, and Civica commercializing it under a private label. In California, the product will be marketed under the CalRx brand. This initiative leverages Biocon Biologics' existing marketing approval for Insulin Glargine-yfgn, which was approved by the US FDA in July 2021 as the first interchangeable biosimilar.

The partnership aims to serve the 38.4m people in the US living with diabetes, addressing the need for high-quality, affordable insulin. Biocon Biologics will retain ownership of the intellectual property and marketing authorization for Insulin Glargine, with no technology transfer involved. This agreement builds upon a prior collaboration where Biocon Biologics agreed to provide Insulin Aspart drug substance to Civica for manufacturing in the United States.

Biocon Biologics, a subsidiary of Biocon Ltd., is a global leader in biosimilars, providing over 9.2bn doses of insulin worldwide. Civica is a non-profit generic pharmaceutical company focused on addressing drug shortages and ensuring a safe, stable, and affordable supply of essential medicines in the US.