Zarxio Launch Update
July 21, 2015 – An appeals court ruled that Sandoz is not required to provide documentation regarding the manufacturing process of its Zarxio (filgrastim-sndz) to Amgen, allowing Sandoz to move forward with the launch of its medication. This is the result of ongoing litigation surrounding the U.S. Food and Drug Administration (FDA) approval of Zarxio (filgrastim-sndz) on March 6, 2015. Zarxio is a non-interchangeable biosimilar to Amgen’s Neupogen (filgrastim) and represents the first FDA approval for a biosimilar.
With the court rulings now finalized, Sandoz is expected to launch Zarxio on September 2, 2015, and it will be available through open distribution. Zarxio was approved for the treatment of 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. The FDA has designated Zarxio with the placeholder nonproprietary name of “filigrastim-sndz”, as a comprehensive naming policy for biosimilars is still being developed.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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