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Cancer

FDA Approves First Biosimilar Product In The US

The FDA has approved Zarxio (filgrastim-sndz), the first biosimilar product to be released in the United States, for indications including certain patients with cancer, leukemia, and neutropenia.

Specifically, Zarxio is indicated for use in the following patients:

  • patients with cancer receiving myelosuppressive chemotherapy;
  • patients with acute myeloid leukemia 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.

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Zarxio is biosimilar to Amgen’s Neupogen (filgrastim), meaning that the 2 products have the same mechanism of action, dosage forms, indications, and conditions of use, and only differ in clinically inactive components.

Approval of Zarxio was based on an evidence review including animal study data, human pharmacokinetic and pharmacodynamics data, structural and functional characterization, clinical immunogenicity data, and other data demonstrating the similarity of Zarxio and Neupogen.

Note: Zarxio was approved as a biosimilar, but not as an “interchangeable product,” meaning that Zarxio cannot be substituted for Neupogen without the intervention of the healthcare provider who originally prescribed Neupogen.

Possible side effects of Zarxio include bone aches, muscle aches, redness, swelling, and itchy at the injection site, spleen rupture, serious allergic reaction, and acute respiratory distress syndrome.

—Michael Potts

Reference:

1. FDA. FDA approves first biosimilar product Zarxio [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Accessed March 6, 2015.