Biologic medicines are among the most innovative drugs to treat many difficult conditions, including cancer and autoimmune diseases. But they are also among the most expensive medicines, accounting for approximately 43% of the total pharmaceutical spending in the United States.
In 2010, an abbreviated regulatory approval pathway was created for a class of biologic medicines called “biosimilars.” The approval pathway created under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)2 aims to provide greater access to biologic medicines by providing additional treatment options that would stimulate market competition and potentially lower the overall cost of healthcare in the United States.