In a highly anticipated decision, the U.S. Supreme Court reduced the time that companies will have to wait before selling lower-cost versions of expensive biologic medicines, a move that is expected to save the health care system piles of money.
The 9-to-0 ruling came in response to sharply contrasting views of the complex procedures found in the Biologics Price Competition and Innovation Act, which is supposed to determine when biosimilar drugs can be launched. In this instance, Sandoz and Amgen are squabbling over competing interpretations.
Much is at stake, however. The U.S. Food and Drug Administration has, so far, approved only four biosimilar medicines, but, in general, these drugs are forecast to save between $27 billion and $58 billion in health care costs by 2021, according to the Quintiles/IMS Institute for Health Informatics.
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