Just after midnight on the morning of Aug. 7, President Trump’s sweeping “reciprocal” tariffs took effect on dozens of international trading partners, marking another dramatic escalation of the administration’s “America First” trading policy.
AMCP Comment Letter on Biosimilar Interchangeability with a Biologic Reference Product
On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic products.
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President Trump signed H.R.1, Republicans’ “big, beautiful” reconciliation bill, into law on July 4, 2025. Starting from that date, the law lays out effective dates and implementation dates for its numerous health provisions over the next few years, and beyond.
AMCP comments on Trump Administration demands for manufacturers to take action on Most-Favored-Nation pricing scheme
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