Nivestym Approved as Biosimilar to Neupogen
July 20, 2018 – The U.S. FDA has approved Nivestym™ (filgrastim-aafi), manufactured by Pfizer, as the second biosimilar to Amgen’s Neupogen® (filgrastim). The first biosimilar to Neupogen, Sandoz’s Zarxio® (filgrastim-sndz), received FDA approval in 2015.
Both Zarxio and Nivestym boost the body’s production of neutrophils, a type of white blood cell important in fighting infection, and share the same indications as their reference product. These indications include reducing the risk of infection for certain patients undergoing myelosuppressive cancer treatment, improving neutrophil recovery in patients with acute myeloid leukemia (AML) who are undergoing chemotherapy, and reducing the duration and incidence of neutropenia (abnormally low neutrophil levels) for certain patient populations.
Recommended dosing with Nivestym is based on the indication. As a biosimilar, it is not automatically interchangeable with Neupogen or Zarxio, but may offer patients a cost-saving alternative. Pfizer expects to make Nivestym available at a significantly lower price than Neupogen’s current wholesale acquisition cost (WAC), though the company has not yet made specific pricing or launch plans available.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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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