U.S. top court grapples over making copycat biologics available sooner

Reuters

26 April 2017 - U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes to bring to the market copycat versions of biologic drugs, expensive medicines that can generate billions of dollars in sales for drug makers.

The nine justices heard arguments in an appeal by Novartis of a lower court decision that prevented the Swiss pharmaceutical company from selling its biosimilar version of Amgen Inc's $1-billion-a-year Neupogen until six months after the FDA approved it.

The ruling in the case, due by the end of June, could determine how quickly patients have access to near-copies of biologic drugs called biosimilars at potentially cheaper prices.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Biosimilar