First Biosimilar, Zarxio Approved
March 4, 2015 – The U.S. Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz), manufactured by Sandoz. Zarxio is a biosimilar compared to Amgen’s Neupogen (filgrastim) and is approved for the same indications as Neupogen. Zarxio is approved for treating 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.
Zarxio will be available in 300 mcg/0.5 mL and 480 mcg/0.8 mL single-use prefilled syringes and the dose of Zarxio varies depending on the indication. Sandoz has agreed to delay the launch of Zarxio until a court decision on Amgen’s request for a preliminary injunction or April 10, 2015, whichever comes first. In addition, a court ruling against Sandoz could delay a launch until the second half of 2015. Zarxio will be available through open specialty pharmacy distribution.
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
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.