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Investing.com -- The U.S. Food and Drug Administration (FDA) announced Wednesday a major overhaul of its biosimilar approval process aimed at making lower-cost alternatives to expensive biologic drugs more accessible to American patients.
The FDA released a new draft guidance that proposes simplifying biosimilarity studies and reducing unnecessary clinical testing requirements. The agency also plans to make it easier for biosimilars to be designated as interchangeable with brand-name biologics, which would allow pharmacists to substitute them more freely.
Biologic medications, while accounting for only 5% of U.S. prescriptions, represent 51% of total drug spending in 2024. Despite FDA-approved biosimilars being as safe and effective as their branded counterparts, they currently hold less than 20% market share.
The FDA has approved 76 biosimilars to date, which corresponds to a small fraction of all approved biologics. By comparison, there are more than 30,000 approved generic drugs, exceeding the number of approved brand-name medications. Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.
"Today’s announcement of biosimilar reform furthers President Trump’s directive to lower drug prices for the American people," said Health and Human Services Secretary Robert F. Kennedy Jr. "Biologics treat many chronic diseases, but for too long, a burdensome approval process has kept patients from accessing more affordable biosimilars."
FDA Commissioner Marty Makary noted that biosimilars "are often far more affordable to patients and have the promise to significantly lower health care costs in America."
The new guidance aims to reduce the need for comparative human clinical studies, which typically take 1-3 years and cost around $24 million on average. Instead, developers can rely more on analytical testing to demonstrate product equivalence.
The FDA also stated it generally no longer recommends "switching studies" for biosimilars seeking interchangeable status, removing a step that has slowed development and created confusion about biosimilar safety.
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