FDA Approves Filkri Biosimilar to Prevent Neutropenia in Blood Cancer

The U.S. Food and Drug Administration (FDA) has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), to help patients with cancer and other conditions recover white blood cells and lower their risk of infection during treatment, according to a news release from Accord BioPharma.

The therapy is part of a class of supportive care drugs known as granulocyte colony-stimulating factors (G-CSFs), which stimulate the body to produce neutrophils, a type of white blood cell that plays a key role in fighting infection.

"Cancer patients often face significant challenges with treatment-related neutropenia, which can lead to serious infections, treatment delays and dose reductions that may compromise therapeutic outcomes," said Chrys Kokino, president of Accord North America. "With Filkri … we now offer healthcare providers a complete G-CSF portfolio with short- and long-acting biosimilar options."

For patients receiving chemotherapy that suppresses the bone marrow, low neutrophil levels (called neutropenia) can lead to serious infections, treatment delays and dose reductions. By helping neutrophils recover more quickly, Filkri may allow some patients to stay on schedule with their cancer treatment and avoid complications related to infection.

What the FDA approval of Filkri means for patients

Filkri is approved for several groups, including patients with cancer receiving myelosuppressive chemotherapy, those with acute myeloid leukemia (AML) undergoing intensive treatment, individuals undergoing bone marrow transplantation and people with severe chronic neutropenia. It is also approved for patients exposed to high levels of radiation that damage the bone marrow.

As a biosimilar, Filkri is highly similar to and has no clinically meaningful differences from Neupogen in terms of safety, purity and effectiveness. Biosimilars often increase access to important biologic medicines by offering additional treatment options that may improve affordability and availability.

The approval may allow care teams to tailor supportive care based on a patient’s treatment plan, risk of neutropenia and scheduling needs.

How Filkri works to reduce infection risk

Neutropenia occurs when chemotherapy damages the bone marrow, reducing the number of neutrophils available to fight bacteria and fungi. G-CSF medicines such as Filkri act on the bone marrow to increase neutrophil production and speed recovery after treatment.

This faster recovery can reduce the duration of neutropenia and lower the chance of febrile neutropenia, a serious complication that often requires hospitalization and intravenous antibiotics. Preventing these complications is an important part of supportive cancer care because infections can interrupt treatment and affect outcomes.

Evidence supporting Filkri

The FDA approval was based on two randomized studies in healthy adults that compared Filkri with the reference product Neupogen. Researchers evaluated how the drug moved through the body (pharmacokinetics), how it affected neutrophil counts (pharmacodynamics), its safety profile and the potential for immune reactions.

The results showed that Filkri matched Neupogen across these measures, with similar neutrophil responses, safety findings and immunogenicity. No clinically meaningful differences were observed between the two products.

The clinical development program focused on demonstrating that Filkri performs the same way as the reference biologic rather than re-proving effectiveness in every disease setting. This is the standard pathway for biosimilar approvals.

Participants in the studies received either Filkri or Neupogen, and investigators measured changes in neutrophil counts, drug exposure levels and adverse events. These data allowed regulators to determine that Filkri provides comparable biologic activity and safety.

Who may receive Filkri

Patients who may benefit include those receiving chemotherapy for solid tumors or blood cancers, individuals with AML during induction or consolidation therapy and patients undergoing bone marrow transplantation. It is also indicated for people with congenital, cyclic or idiopathic severe chronic neutropenia and for those exposed to bone marrow-suppressing radiation.

As with other G-CSFs, Filkri is not used at the same time as chemotherapy or radiation and is typically given after treatment to support blood count recovery.

Safety and side effects to know

The most common side effects associated with filgrastim products include fever, bone or muscle pain, rash, cough and shortness of breath. Rare but serious risks include splenic rupture, acute respiratory distress syndrome, severe allergic reactions and capillary leak syndrome. Patients with sickle cell disease may experience severe crises, and monitoring is recommended for those with chronic neutropenia due to a potential risk of myelodysplastic syndrome or acute myeloid leukemia.

Patients should report symptoms such as left upper abdominal pain, difficulty breathing, swelling or signs of infection to their care team promptly.

Expanding access to supportive cancer care

Supportive therapies such as G-CSFs are a critical part of cancer treatment because they help patients tolerate chemotherapy safely. The addition of a new biosimilar may improve access to these medicines and give providers more flexibility in choosing the right option for each patient.

As biosimilars continue to enter the oncology space, they are expected to play a growing role in reducing costs and expanding availability of essential supportive care treatments that help patients stay on track with therapy and maintain quality of life.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.

References

1. “FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma's Biosimilar to NEUPOGEN® (filgrastim),”by Accord BioPharma. News release; Feb. 17, 2026.

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