January 15, 2026 -- The U.S. Food and Drug Administration has approved Filkri (filgrastim-laha), a biosimilar to Neupogen from Accord BioPharma, Inc.

Filkri is a leukocyte growth factor indicated to:

• Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
• Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
• Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
• Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).Filkri

Filkri will be available in two injection presentations:

• 300 mcg/0.5 mL in a single-dose prefilled syringe
• 480 mcg/0.8 mL in a single-dose prefilled syringe

Filkri is a human granulocyte colony-stimulating factor (G-CSF) manufactured using recombinant DNA technology. As a biosimilar to Neupogen, Filkri has been demonstrated to be highly similar to the reference product with no clinically meaningful differences in terms of safety, purity and potency.

G-CSF is a naturally ocurring protein that stimulates the production of neutrophils, a type of white blood cell essential for fighting infections. By regulating neutrophil production within the bone marrow, Filkri works to help patients maintain adequate white blood cell counts in patients receiving cancer treatment and patients requiring support for chronic neutropenic conditions.

Filkri is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Warnings and precautions associated with Filkri include:

• Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
• Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue Filkri in patients with ARDS.
• Serious allergic reactions, including anaphylaxis: Permanently discontinue Filkri in patients with serious allergic reactions.
• Fatal sickle cell crises: Discontinue Filkri if sickle cell crisis occurs.
• Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Filkri if causality is likely.
• Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using Filkri in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
• Thrombocytopenia: Monitor platelet counts.
• Aortitis: Aortitis has been reported in patients receiving filgrastim products. Discontinue Filkri if aortitis is suspected.

Adverse Reactions

Most common adverse reactions in patients:

• With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea.
• With AML (≥ 2% difference in incidence) are pain, epistaxis and rash.
• With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash.
• With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.

Filkri is the fifth FDA-approved biosimilar to Neupogen, after the approvals Nypozi (filgrastim-txid) in 2024, Releuko (filgrastim-ayow) in 2022, Nivestym (filgrastim-aafi) in 2018, and Zarxio (filgrastim-sndz) in 2015.

Source: Drugs.com