From 2015 to 2020, FDA approvals of "skinny labels" on biosimilars saved Medicare $1.5 billion, according to a study published Nov. 28 in the Journal of the American Medical Association.
Biosimilars are generic versions of biologics, and drugmakers often work to prevent copycat drugs because biologics, which are less than 5 percent of prescription drug use, account for about 40 percent of U.S. drug spending. Through detailing a nonpatented use of a biosimilar, the FDA's "skinny label" rule allows an easier pathway for biosimilars to enter the market without the risk of patent litigation.
During that five-year period, Medicare spent $30.2 billion on five biologics. The researchers from Brigham and Women's Hospital and Harvard Medical School, both based in Boston, found that about 66 percent of 33 biosimilars based on 11 biologics had a skinny label, which they estimate cut Medicare's spending by $1.5 billion.
That number will "likely grow substantially" after biosimilars for Humira — which has made AbbVie $200 million — become available in 2023, according to the researchers.