The U.S. Food and Drug Administration (FDA) has unveiled a new draft guidance aimed at making the development of biosimilar medicines—lower-cost alternatives to expensive biologic drugs—faster, simpler, and less costly. The move is part of a broader effort to boost market competition, lower drug prices, and expand access to life-saving treatments for chronic and serious diseases.
The FDA’s proposed framework updates requirements for demonstrating biosimilarity, significantly reducing the need for costly and time-consuming clinical studies. The agency will instead allow developers to rely more heavily on analytical testing to confirm similarity to branded biologics. The FDA also announced a separate initiative to make it easier for biosimilars to achieve “interchangeable” status, enabling patients and pharmacists to substitute them more freely for brand-name drugs.
Biologic drugs represent only 5% of U.S. prescriptions but account for over half of total drug spending, according to 2024 data. While the FDA has approved 76 biosimilars to date, their market penetration remains limited, with biosimilars comprising less than 20% of biologic sales.
“Today’s announcement furthers the Administration’s mission to lower drug prices for Americans,” said Health and Human Services Secretary Robert F. Kennedy Jr. “This bold action accelerates biosimilar development, drives competition, and expands affordable treatment options.”
FDA Commissioner Marty Makary, M.D., M.P.H., added, “Biosimilars are as safe and effective as their branded counterparts but often much more affordable. By streamlining their approval and advancing interchangeability, we can significantly cut healthcare costs for millions of patients.”
The new draft guidance, titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies,” reflects nearly a decade of FDA experience since the first biosimilar approval in 2015. The agency noted that comparative efficacy trials—typically costing up to $24 million and taking several years—often add little scientific value.
George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research, emphasized that the updated approach “balances scientific rigor with efficiency,” ensuring continued safety and effectiveness without unnecessary burdens.
By simplifying biosimilar and interchangeable biosimilar development, the FDA hopes to increase competition in the biologics market and deliver affordable, high-quality therapies for diseases such as cancer, diabetes, rheumatoid arthritis, and Crohn’s disease—ultimately helping Americans access innovative treatments at lower cost.