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Sandoz Zarxio Launch Still Faces Hurdles; ‘Chess Game’ With Amgen Continues

 
• By Brenda Sandburg

Federal Circuit ruling frees Sandoz to begin marketing first U.S. biosimilar after Sept. 2 but it still must overcome pending infringement suit and chance Amgen will assert more patents.

Sandoz Inc. is free to begin marketing Zarxio (filgrastim-sndz) as of Sept. 2 in the wake of the Federal Circuit’s decision affirming its interpretation of the biosimilars statute. But there are drawbacks to the launch given ongoing infringement litigation and the outcome of possible appeals of the court ruling.

A three-judge panel of the U.S. Court of Appeals for the Federal Circuit ruled July 21 that Sandoz did not have to engage in the patent exchange process laid out...

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