November 29, 2016 / 12:06 PM / a year ago

Supreme Court to consider reviewing delay of biosimilar launch

The Supreme Court will consider early next month whether to grant a petition for review that would require it to interpret the federal law on copycat biologic drugs for the first time, in a case that involves a bid by Apotex Inc to make biosimilar versions of Amgen Inc’s white-blood-cell-boosting drugs Neulasta and Neupogen.

Apotex is asking the court to overturn an order requiring it to wait at least 180 days after receiving approval from the U.S. Food and Drug Administration to launch the drugs. In its petition, filed in September, Apotex said the federal law on biosimilars allowed it to launch the drugs as soon as they were approved.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2fxhk03

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