U.S. Supreme Court

Supreme Court to hear case that affects how quickly biosimilar drugs are marketed

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The U.S. Supreme Court on Friday agreed to hear a case that could resolve how quickly patients will have access to copycat versions of biologic drugs.

At issue is whether companies that make the copycat drugs, known as “biosimilars,” must wait six months after getting federal approval to begin marketing the medicine, Reuters reports. Biologic drugs are isolated from living organisms, and they can’t be exactly copied for generics, the article explains. Bloomberg News also has a story.

A federal law requires biosimilar drugmakers to give brand-name drug manufacturers 180 days’ notice before selling the copycat version. At issue is whether the time begins to run after approval from the Food and Drug Administration.

The case involves an application by Novartis AG’s Sandoz unit to sell a biosimilar drug called Zarxio. The drug copies an Amgen biologic called Neupogen that boosts white blood cell counts in cancer patients.

Both companies are appealing parts of a decision by the U.S. Court of Appeals for the Federal Circuit. Sandoz is challenging the court’s decision on notice. Amgen is challenging the court’s finding that Sandoz wasn’t required to give Amgen a copy of its biosimilar license application and related manufacturing information.

The cases are Sandoz v. Amgen and Amgen v. Sandoz. The SCOTUSblog case pages are here and here.

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