US lawmakers introduce bill to streamline biosimilar approvals
US lawmakers have introduced bipartisan legislation that would reduce routine reliance on comparative clinical efficacy studies in biosimilar approvals, a move welcomed by the Association for Accessible Medicines (AAM) and its Biosimilars Council.
The Expedited Access to Biosimilars Act, sponsored in the House by Representative Nick Langworthy and Representative Kim Schrier, would amend the Public Health Service Act to make clear that biosimilar licensing should not generally require studies assessing pharmacodynamics or comparative clinical efficacy.
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