During oral arguments at the U.S. Supreme Court, Amgen and Sandoz clashed over the intent of the Biologics Price Competition and Innovation Act in a case set to have a big impact on future biosimilar launches.

Lawyers for the two companies fielded a host of questions from the justices, with attention centering on two key issues: One, whether biosimilar companies should be required to hand over their full FDA approval applications to the makers of the original branded product; and two, when the biosim companies are able to provide “notice” of their intent to market a biosim, thus triggering a six-month waiting period.

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