FDA Approves Second Neupogen Biosimilar, Nivestym

The FDA on Friday approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.

“The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy,” said Berk Gurdogan, US institutions president for Pfizer Essential Health, in a statement made to The Center for Biosimilars^®. “We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”

The drug is approved for the same indications as the reference product, including decreasing the incidence of infection due to neutropenia. Specifically, the drug has been approved to treat side effects from cancer treatment for patients:

• With acute myeloid leukemia receiving induction or consolidation chemotherapy
• With cancer receiving myelosuppressive chemotherapy
• With cancer undergoing bone marrow transplant
• Undergoing autologous peripheral blood progenitor cell collection and therapy
• With severe chronic neutropenia

Nivestym will prospectively follow Sandoz’s Zarxio to the United Sates market for filgrastim. Zarxio was not only the first filgrastim to reach American patients (prior to implementation of the Biologics Price Competition and Innovation Act—BPCIA—pathway, tbo-filgrastim was approved as a follow-on drug), but also the first biosimilar approved in the United States under the BPCIA pathway.

Since its introduction, the supportive care product, which is a less complex molecule than an anticancer molecule such as trastuzumab or bevacizumab, has gained general acceptance among providers and patients, and it has allowed for cost savings in clinical practice.

Pfizer has not yet announced how it will price its biosimilar filgrastim to compete with tbo-filgrastim, Zarxio, or the reference product, nor has it supplied a prospective launch date for the drug.

Nivestym is the third biosimilar approved in 2018; the most recent biosimilar to receive FDA approval was pegfilgrastim-jmdb in June 2018. The product was developed in a joint partnership by Mylan and Biocon which will be sold under the brand name Fulphila. Prior to Fulphila, the FDA approved Pfizer’s biosimilar epoetin alfa, referencing Epogen.