FDA Approves Filkri, Filgrastim Biosimilar Referencing Neupogen for Cancer Treatment–Related Indications

The FDA has approved a filgrastim biosimilar, Filkri (filgrastim-laha; Accord BioPharma), a product referencing Neupogen (Amgen), for the following indications¹:

• Patients with cancer receiving myelosuppressive chemotherapy
• Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy
• Patients with cancer undergoing bone marrow transplantation
• Patients with severe chronic neutropenia, and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).

Reference filgrastim is used to treat neutropenia (low white blood cell count) caused by cancer treatments. It is a synthetic form of a colony-stimulating factor, a naturally produced substance. When certain cancer medicines are used to treat cancer cells, they also affect the white blood cells that fight infections. Filgrastim is used to prevent or reduce the risk of infections in patients receiving cancer medicines. Additionally, filgrastim is also used to help the bone marrow recover after a bone marrow transplantation, for peripheral blood progenitor cell collection in patients with cancer, and to improve survival in patients with cancer who have been exposed to radiation.²

Colony-stimulating factors are glycoproteins that act on hematopoietic cells by binding to specific cell-surface receptors and stimulating proliferation, differentiation, commitment, and, in some cases, end-cell functional activation. Endogenous granulocyte colony-stimulating factor (G-CSF) is a lineage-specific colony-stimulating factor produced by monocytes, fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils in the bone marrow and affects neutrophil progenitor proliferation, differentiation, and selected end-cell functions, including enhanced phagocytic ability, priming of cellular metabolism associated with the respiratory burst, antibody-dependent killing, and increased expression of some cell surface antigens.³

According to Filkri’s prescribing information, phase 1 pharmacodynamic studies in patients with various nonmyeloid malignancies demonstrated that Filkri increased circulating neutrophil counts in a dose-dependent manner over the dose range of 1 to 70 μg/kg daily. This increase in neutrophil counts was observed whether Filkri was administered intravenously (1-70 μg/kg twice per day), subcutaneously (1-3 μg/kg once per day)‚ or by continuous subcutaneous infusion (3-11 μg/kg once per day). When therapy was discontinued, neutrophil counts returned to baseline in most cases within 4 days. Additionally, isolated neutrophils displayed normal phagocytic and chemotactic activity in vitro.³

The absolute monocyte count increased in a dose-dependent manner in most patients receiving filgrastim; however, the percentage of monocytes in the differential count remained within the normal range. Absolute counts of both eosinophils and basophils remained unchanged and within the normal range following filgrastim administration. Increases in lymphocyte counts following filgrastim administration have been reported in some patients, including those with cancer. White blood cell differentials obtained during clinical trials showed a shift toward earlier granulocyte progenitors, typically during neutrophil recovery. In addition, Döhle bodies, increased granulocyte granulation, and hypersegmented neutrophils have been observed. Such changes were transient and not associated with clinical sequelae, nor were they necessarily associated with infection.³

Filkri is available in 2 injection presentations: 300 μg/0.5 mL and 480 μg/0.8 mL, both in single-dose prefilled syringes. Exact dosing depends on the patient and the reason for treatment. The most common adverse events reported by patients include pain, pyrexia, rash, cough, dyspnea, epistaxis, anemia, diarrhea, hypoesthesia, and alopecia.³

“[Patients with cancer] often face significant challenges with treatment-related neutropenia, which can lead to serious infections, treatment delays, and dose reductions that may compromise therapeutic outcomes,” Chrys Kokino, president at Accord North America, said in a news release. “With Filkri alongside Udenyca, the provider-preferred option over Neulasta and all other biosimilars, we now offer health care providers a complete G-CSF portfolio with short- and long-acting biosimilar options.”¹

REFERENCES

1. FDA approves Filkri (filgrastim-laha), Accord BioPharma’s biosimilar to Neupogen (filgrastim). News release. Accord BioPharma. February 17, 2026. Accessed February 17, 2026. https://www.prnewswire.com/news-releases/fda-approves-filkri-filgrastim-laha-accord-biopharmas-biosimilar-to-neupogen-filgrastim-302689073.html

2. Filgrastim (injection route). Mayo Clinic. Updated February 1, 2026. Accessed February 17, 2026. https://www.mayoclinic.org/drugs-supplements/filgrastim-injection-route/description/drg-20071547

3. Filkri injection. Prescribing information. Accord BioPharma; 2026. Accessed February 17, 2026. https://www.accordbiopharma.com/our-therapies/filkri/filkri_pi.pdf