STAT Plus: Will the ‘patent dance’ cause Amgen to temporarily pull a biosimilar off the market?
In a closely watched case, a federal appeals court must decide whether a biosimilar company should temporarily pull its product off the market because manufacturing plants may be changed, a move that could cause Americans to pay more for a brand-name biologic medicine — at least for a few months.
At issue is an interpretation of federal law known as the Biologics Price Competition and Innovation Act, which is supposed to determine when biosimilar drugs can be launched. A biosimilar is a nearly identical variant of a biologic and is expected to provide the same result in patients, while costing less money. So the timing of any biosimilar product launch has implications for the U.S. health care system.
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