Tuesday, 10 March 2015

FDA approves first biosimilar product in the USA

On 6 March 2015 the US Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States.

Sandoz Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:
  • patients with cancer receiving myelosuppressive chemotherapy;
  • patients with acute myeloid leukaemia receiving induction or consolidation chemotherapy;
  • patients with cancer undergoing bone marrow transplantation;
  • patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
  • patients with severe chronic neutropenia.
Read more here.

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