The FDA has announced it will undertake steps to accelerate the process of developing biosimilars, while also reducing development costs.
In new draft guidance, the agency proposes major updates to simplify how biosimilars are tested and to reduce unnecessary clinical trials. The FDA also plans to make it easier for biosimilars to be approved as interchangeable with brand-name biologics, allowing patients and pharmacists to choose lower-cost options more easily.
Biologics vs biosimilars
In a press release, the administration noted that biologic drugs account for only about 5% of prescriptions in the US, but accounted for 51% of total drug spending as of 2024.
Although biosimilars are regarded as just as safe and effective as the original products, they currently hold less than 20% of the market. Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.
The path ahead
“Today’s announcement of biosimilar reform furthers President Trump’s directive to lower drug prices for the American people,” said Robert F. Kennedy Jr, Health and Human Services Secretary, in the release. “This bold action by the FDA accelerates biosimilar development, drives market competition, expands patient options and advances our mission to Make America Healthy Again.”
The FDA’s new draft guidance builds on data gathered since the first biosimilar approval in 2015. The agency found that comparative efficacy studies, often taking 1-3 years and costing around $24m, are generally less sensitive than other analytical methods. The updated guidance now reduces the need for these costly clinical studies, allowing developers to rely more on analytical testing to show product differences.
Cheaper drug options for the US
Also commenting in the release was George Tidmarsh, Director, FDA Center for Drug Evaluation and Research, who said that “science continues to evolve, and the FDA remains committed to advancing common-sense policies that further promote efficient and effective biosimilar and interchangeable biosimilar development, without compromising safety and effectiveness”.
The agency also no longer generally recommends “switching studies” for biosimilars seeking interchangeability. With these changes, the FDA hopes to bring more affordable biologic alternatives to patients faster and lower overall healthcare costs.
