Skinny-Label Biosimilars Saved Medicare $1.5 Billion Through 2020

“Skinny-label” biosimilars, or biosimilar drugs that exclude indications still protected by patents or regulatory exclusivities, saved Medicare an estimated $1.5 billion between 2015 and 2020, according to a research letter published in JAMA Internal Medicine.

“Although biologics comprise fewer than 5% of prescription drug use, they account for approximately 40% of US drug spending,” explained corresponding author Ameet Sarpatwari, PhD, JD, and study coauthors from Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts. “Biologic manufacturers often take steps to delay availability of biosimilars, including by obtaining patents and regulatory exclusivities for supplemental indications that expire years after those covering the biologic’s original indications.”

To work against such delays, federal law allows the US Food and Drug Administration to approve skinny-label biosimilars for selected indications. The study looked at skinny-label biosimilar approval and marketing in recent years and its impact on Medicare spending.

Between 2015 and 2021, 33 biosimilars of 11 biologic drugs received FDA approval. Two-thirds of the biosimilars had skinny labels, according to the study. Among 21 biosimilars marketed before 2022, 13 had skinny labels.

First-to-market biosimilars with skinny labels sped up competition by a median 2.5 years, the study found. Between 2015 and 2020, skinny-label biosimilars saved Medicare an estimated $1.5 billion across 5 biologics. The estimated savings was $925 million in a sensitivity analysis that did not adjust for price changes over the period.

“Skinny labeling for biosimilars is important to ensure timely competition for biologics, helping make these medications more affordable and accessible,” researchers wrote.

Reference

Egilman AC, Van de Wiele VL, Rome BN, et al. Frequency of approval and marketing of biosimilars with a skinny label and associated Medicare savings. JAMA Intern Med. 2023;183(1):82-84. doi:10.1001/jamainternmed.2022.5419