FDA approves first biosimilar Zarxio™ (filgrastim-sndz) from Sandoz

  • Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under BPCIA
  • Zarxio is approved for all indications included in the reference product’s (NEUPOGEN®) label
  • Approval paves way for greater access to high-quality biologics in the US and underscores Sandoz global leadership in biosimilars

Holzkirchen, March 06, 2015 – Sandoz, a Novartis company, announced today that the US Food and Drug Administration (FDA) approved ZarxioTM (filgrastim-sndz) for all …

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FDA approves first biosimilar Zarxio™ (filgrastim-sndz) from Sandoz

  • Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under BPCIA
  • Zarxio is approved for all indications included in the reference product’s (NEUPOGEN®) label
  • Approval paves way for greater access to high-quality biologics in the US and underscores Sandoz global leadership in biosimilars

Holzkirchen, March 06, 2015 – Sandoz, a Novartis company, announced today that the US Food and Drug Administration (FDA) approved ZarxioTM (filgrastim-sndz) for all …

/by