The US Food and Drug Administration (FDA) has approved filgrastim-aafil (Nivestym, Pfizer), a biosimilar filgrastim (Neupogen, Amgen), making it the second biosimilar for this agent in the United States.
Filgrastim is a recombinant human granulocyte colony-stimulating factor with several clinical uses, including aiding recovery from neutropenia in cancer patients undergoing chemotherapy.
Indications for the new biosimilar are the same as for filgrastim, which has been approved for use in cancer patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia (AML) receiving induction or consolidation chemotherapy, those undergoing bone marrow transplantation, those undergoing autologous peripheral blood progenitor cell collection and therapy, and those with severe chronic neutropenia.
The first biosimilar product for filgrastim, and the first one to receive approval in the United States, was filgrastim-sndz (Zarxio, Sandoz/Novartis), which got a thumbs up from the FDA in 2015. The product had already been marketed in Europe (since 2008) and in many other countries under the name Zarzio.
At the time of its approval, Louis Weiner, MD, chair of the department of oncology and director of the Georgetown Lombardi Comprehensive Cancer Center at Georgetown University in Washington, DC, said in a statement issued by Novartis that Neupogen "is underused in the United States for a variety of reasons, including price.
"Biosimilars have the potential to increase access, and the approval of Zarxio may reduce costs to the healthcare system," Weiner said.
According to the manufacturer, today's approval of Nivestym was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity compared with its reference product. It is expected to be available in the United States at a significantly lower price compared with the current wholesale acquisition cost of Neupogen.
"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, Pfizer Essential Health, in a statement.
Most common adverse reactions in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs are pyrexia, pain, rash, cough, and dyspnea. With AML specifically, common adverse effects are pain, epistaxis, and rash.
Among patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplant, the most common adverse event is rash. For those undergoing peripheral blood progenitor cell mobilization and collection, adverse events include bone pain, pyrexia, and headache.
Finally, common adverse events for patients with severe chronic neutropenia include pain, anemia, epistaxis, diarrhea, hypoesthesia, and alopecia.
Nivestym has been marketed in the European Union since 2010 (under the name Nivestim) to prevent febrile neutropenia and reduce the duration of chemotherapy-induced neutropenia.
Cite this: Second Filgrastim Biosimilar Gets Thumbs Up From the FDA - Medscape - Jul 20, 2018.