Biosimilars are an important topic in U.S. health care news in the summer of 2021. July 9, President Joe Biden signed an executive order to promote competition in the American economy. In the health care portion of the order, President Biden directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, which provide low-cost options for patients. https://www.whitehouse.gov
Some two weeks later, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar insulin product, Semglee, indicated to improve glycemic control in adults and children with Type 1 diabetes, and adults with Type 2 diabetes. This is the 30th biosimilar to be approved by the FDA, and more applications are in process.
“Biological products are the fastest-growing class of therapeutic products in the United States and account for a substantial and increasing portion of health care costs,” the FDA states. Biologics include vaccines, blood components, allergenics and gene therapy. They are used to treat many serious illnesses and chronic health conditions. Biosimilars are products with no clinically meaningful difference from the original biologic, in terms of safety, purity or potency.
The Biologics Price Competition and Innovation Act, passed by Congress in 2009, created a licensure pathway for biosimilars. The FDA states that “biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.”