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 (aBLAs) 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.