Posted from: Tuesday, August 07, 2018 - 01:46 PM - Present

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.

 

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 U.S. mail or by fax.

Actual drug patent expiration dates and 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.

Last Updated Monday, December 10, 2018 - 12:53 PM.