Biosimilars Caught In Crosshairs Of Supreme Court ACA Fight

Law360 (November 9, 2020, 8:24 PM EST) -- The U.S. Supreme Court is set to hear oral arguments Tuesday in a case challenging the Affordable Care Act, and while all eyes have been focused on whether conservative justices will strike down former President Barack Obama's landmark health insurance expansion, a critical provision governing biosimilars is also at stake.

The Biologics Price Competition and Innovation Act, which was passed as Title VII of the ACA, provides a regulatory pathway for similar or copycat versions of patent-protected biologics to get to market, comparable to the Hatch-Waxman Act for small-molecule drugs. If the entire act is found to be unconstitutional, then biosimilar makers will face...

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