September 3, 2015
The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.’s attempt to stall the launch. The launch follows FDA approval of Zarxio™ on March 6, 2015 and a Federal Circuit panel decision in July preventing Sandoz from marketing Zarxio™ until 180 days after FDA licensure (i.e., until September 2, 2015). The launch of Zarxio™ does not quell the legal dispute between Sandoz and Amgen Inc., as both parties have asked the full Federal Circuit to review the panel decision.

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