Biosimilars Have Saved Billions Over 10 Years; More Agents, Savings Are Expected
-
Apr 10, 2025
It wasn’t until five years after then-President Barack Obama signed the Affordable Care Act (ACA) into law on March 23, 2010, establishing the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), that the FDA approved the first biosimilar. Although the market started slowly and still experiences challenges in getting uptake of these agents, biosimilars have saved the U.S. health care system billions of dollars, observes Cardinal Health in its new report, 10 Years of Biosimilars: 2015–2025.
The FDA approved the first biosimilar, Sandoz’s Zarxio (filgrastim-sndz), on March 6, 2015. The biosimilar of Amgen Inc.’s Neupogen (filgrastim) was the only one of its kind to gain approval that year, followed by three more the following year. Single-digit approvals would follow until 2019, which had 10 approvals, but then 2020 had only three. 2024, however, saw 19 biosimilar approvals, and with the nine as of early April 2025, the FDA had given its blessing to 73 of the agents, representing almost 20 molecules.
Read more
© 2024 MMIT
The Latest
Meet Our Reporters
Meet Our Reporters
GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND
Sign up for publications to get unmatched business intelligence delivered to your inbox.