The US Food and Drug Administration (FDA) has introduced significant measures aimed at expediting and reducing the costs associated with the development of biosimilar medicines—affordable alternatives to biologic drugs utilized in the treatment of serious and chronic conditions.
In a new draft proposal, the FDA outlines substantial updates designed to simplify biosimilarity studies and eliminate unnecessary clinical trials. Additionally, a parallel initiative aims to facilitate the development of biosimilars as interchangeable with brand-name biologics, thereby assisting patients and pharmacists in accessing more affordable options.
Although biologic medications constitute just 5 percent of prescriptions in the United States, they account for 51 percent of total drug spending as of 2024. Biosimilars approved by the FDA are deemed as safe and effective as their branded counterparts; however, their market penetration remains under 20 percent. To date, the FDA has sanctioned 76 biosimilars, which represents only a small fraction of the total number of approved biologic drugs. In contrast, over 30,000 generic medications have been approved, surpassing the number of branded drugs. Currently, only about 10 percent of biologic drugs expected to lose patent protection in the next decade have a biosimilar in development.
The reform of biosimilars aligns with the directive from US President Donald Trump aimed at lowering drug prices for Americans. Health and Human Services Secretary Robert F. Kennedy Jr. stated, “Biologics treat many chronic diseases, but, for too long, a burdensome approval process has kept patients from accessing more affordable biosimilars. This bold action by the FDA accelerates biosimilar development, drives market competition, and expands patient options.”
FDA Commissioner Marty Makary emphasized the potential economic benefits, noting, “Biosimilars are often far more affordable to patients and have the promise to significantly lower healthcare costs in America. By streamlining the biosimilar development process and assisting in advancing interchangeability, we can achieve substantial cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans.”
(Source: USFDA)
Published on November 3, 2025
