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- 01/16/2017

U.S. Supreme Court wil hear dispute over biosimilars patent law

Pharma Horizon

The U.S. Supreme Court will hear a case on the issue on how long companies have to wait to marketing biosimilars after getting federal approval. This would be the first time the high court will interpret a 2010 provision of Obamacare that enabled the U.S. Food and Drug Administration to approve biosimilars.

At the moment the patent law requires biosimilar drugmakers to give brand-name drug manufacturers  six months notice before selling the low-cost alternatives.

The case is focusing on Novartis AG’s Sandoz unit that sell a copy of Amgen Inc.’s Neupogen, a white blood cell booster: sandoz began selling Zarxio, the first biosimilar of any drug in the U.S., in September 2015.

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 hearing wil be starting in April, with a decision expected by July

Mylan NV and Pfizer Inc.’s Hospira were among those backing Sandoz’s appeal.



Source: Reuters


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