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Amgen Fight Over Copies of Biotech Drugs Gets High Court Review

Photographer: Dario Pignatelli/Bloomberg

The U.S. Supreme Court agreed to hear a dispute that could help clarify the steps needed to get low-cost alternatives to pricey biotechnology drugs on the market.

It will be the first time the high court has agreed to interpret a 2010 provision of Obamacare that enabled the U.S. Food and Drug Administration to approve biosimilars, which are copies of medicines based on living organisms. The law created a complex set of steps known as a “patent dance” that courts and regulators have struggled to interpret.