The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...
Biologics eat 51% of drug spending despite 5% of prescriptions, but FDA's new draft guidance hopes more competition can close that gap.
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical ...
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