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The United States’ First-Ever Biosimilar Reaches the Market

Today, Sandoz (a Novartis subsidiary) launched the first biosimilar approved under the BPCIA: the cancer drug Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen’s Neupogen.  The launch follows the Federal Circuit’s decision enjoining Sandoz from launching Zarxio for 180 days and the court’s recent denial of Amgen’s emergency motion to extend the injunction pending Amgen’s and Sandoz’s cross-petitions for rehearing en banc.  Specifically, in July, a divided Federal Circuit panel blocked Zarxio’s launch until today, holding that the BPCIA’s notice of commercial marketing provision – requiring a biosimilar to provide 180 days before first commercial marketing – was mandatory and that Sandoz’s notice was not effective until the FDA had approved its application (thus making today the earliest launch date).  Whether the en banc Federal Circuit will take up either Amgen’s or Sandoz’s petition, and if so, what remedy will be available to either party, remains to be seen.

The launch of Zarxio provides the first data point concerning price savings from biosimilars.  Sandoz indicated that Zarxio’s Wholesale Acquisition Cost (WAC) will be approximately 15% lower than that of Neupogen.  This discount is similar to that set when Zarxio first launched in Europe in 2009.

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