A Supreme Court chill across biosimilar 'skinny' labels could halt billions in Medicare savings
As generic drugmakers continue to petition the US Supreme Court to protect a longstanding precedent that allows them to carve out and market certain indications for a patented brand name drug — under what’s known as a “skinny” label — new research also raises questions about billions in savings lost from skinny biosimilar labels if courts leave this pathway in limbo.
A JAMA research letter published yesterday notes that of 21 biosimilars marketed before 2022, 13 (62%) were launched with a skinny label. Annual estimated savings from those skinny labels increased from $2 million in 2015 to $857 million in 2020 as more biologics ran into this biosimilar competition.
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