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U.S. Supreme Court speeds copycat biologic drugs to market
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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 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.
The dispute involved a section of the 2010 Affordable Care Act, dubbed Obamacare, that created an expedited path for regulatory approval of biosimilars while trying to respect the patent rights of brand-name manufacturers.
Novartis complained that the 2015 ruling by the U.S. Court of Appeals for the Federal Circuit in Washington handed Amgen an extra six months of exclusivity on top of the 12 years already provided under the law.
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