Reuters, Andrew Chung, Jun 12, 2017

The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies.

The justices, in a 9-0 ruling, overturned a lower court’s decision that had prevented Swiss pharmaceutical company Novartis AG from selling its copycat version of California-based Amgen Inc’s Neupogen until six months after the U.S. Food and Drug Administration approved it.

The decision has major implications for the pharmaceutical industry because it will dictate how long brand-name makers of biologic drugs can keep near-copies, called biosimilars, off the market. Even the six months at issue in the case can mean hundreds of millions of dollars in sales.

Health insurers expect biosimilars to be cheaper than original brands, like generics, saving consumers billions of dollars each year.

Novartis said in a statement that the ruling “will help expedite patient access to life-enhancing treatments.”

Amgen spokeswoman Kelley Davenport said the company was disappointed but “will continue to seek to enforce our intellectual property against those parties that infringe upon our rights.”

 

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