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US FDA proposes streamlined biosimilar drug study, testing requirements

( October 29, 2025, 19:23 GMT | Official Statement) -- MLex Summary: The US Department of Health and Human Services issued a statement regarding the Food and Drug Administration's new proposed "major updates" which would streamline biosimilar drug studies and reduce unnecessary clinical testing. In the new draft guidance, the FDA plans to make it easier for biosimilars to be developed, encouraging more lower-cost options for patients and pharmacists outside of brand-name drugs, the HHS said in a statement. “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, expands patient options, and advances our mission to Make America Healthy Again," US Health and Human Services Secretary Robert F. Kennedy Jr. said in the HHS statement.Full statement follows:...

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