The Value of Being Highly Similar: First U.S. Biosimilar

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform, the Affordable Care Act, signed into law by President Barack Obama in March 2010. The BPCIA created an abbreviated regulatory pathway for marketing approval of biologic medicinal products that are ‘‘biosimilar’’ to an already approved product. On March 6, the Food and Drug Administration (FDA) approved the first biosimilar in U.S. history—Sandoz’s biosimilar of Amgen’s blockbuster drug used to prevent infections in cancer patients, Neupogen. Sandoz, a Novartis company, reaped tremendous savings in cost and time by taking advantage of the new biosimilar pathway rather than submitting a full biologics license application (BLA) to the FDA and undertaking all the studies that Amgen had to perform to obtain approval for Neupogen. The extent to which these savings will be passed on to the U.S. health care system as envisioned by the Obama administration, however, is less clear.