Bengaluru-based Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, and Civica, Inc., a not-for-profit generic drug and pharmaceutical company founded in 2018 to address and resolve life-saving drug shortages and affordability, have announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the United States (US).
Under the terms of the agreement, Biocon Biologics will supply Insulin Aspart drug substance to Civica, Inc., who will use the drug substance to produce Insulin Aspart drug product, a rapid-acting insulin analog, at its manufacturing facility in Petersburg, Virginia. Civica will commercialise the medicine for patients in the United States, after completion of development work and clinical trials. No technology transfer is involved in the agreement.
This collaboration is in addition to Biocon Biologics’ own Insulin Aspart Drug Product for the United States which is currently under US Food and Drug Administration (FDA) review.
There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.
