FDA Approves Filkri, Accord BioPharma’s Short-Acting Filgrastim Biosimilar for Neutropenia

Filkri (filgrastim-laha; Accord BioPharma), a biosimilar to Neupogen (filgrastim; Amgen), was FDA-approved for the treatment of neutropenia, based on 2 randomized studies.1

Filkri belongs to the granulocyte colony-stimulating factor (G-CSF) class and is the first short-acting G-CSF biosimilar under Accord Biopharma. G-CSF biosimilars are growth factors manufactured by recombinant DNA technology that regulate the production of neutrophils within bone marrow, a particularly significant treatment for patients undergoing chemotherapy. Neutropenia is common in patients receiving chemotherapy; serious complications can arise during cancer treatments, thus reducing patients’ white blood cell count or neutrophils and increasing the likelihood of patients developing an infection. This addition has expanded Accord BioPharma’s catalog of G-CSF-class biosimilars, which previously included only Udenyca (pegfilgrastim-cbqv; Accord BioPharma)—a long-acting option the company acquired last year. Now with both biosimilars, Accord Biopharma has 6 biosimilars and 7 total products in its portfolio.

"With FILKRI alongside UDENYCA, the provider-preferred option over Neulasta and all other biosimilars, we now offer healthcare providers a complete G-CSF portfolio with short- and long-acting biosimilar options,” Chrys Kokino, president of Accord North America, said in a press release. “This positions Accord BioPharma as a committed partner in oncology supportive care, expanding access to high-quality biologics."

Filkri Approval Strengthens Accord’s G-CSF Biosimilar Portfolio in Oncology Supportive Care

Filkri was approved to treat patients with cancer receiving myelosuppressive chemotherapy or undergoing a bone marrow transplant, patients with acute myeloid leukemia (AML) receiving induction or consolidation therapy, patients with severe chronic neutropenia, and patients acutely exposed to myelosuppressive doses of radiation.

The approval was based on results from 2 randomized studies in healthy adults assessing safety and efficacy in both studies and pharmacokinetics/pharmacodynamics in one, compared with Neupogen. The overall findings showed the safety and immunogenicity of Filkri were similar to those of Neupogen.

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Patients who received Filkri with nonamyloid malignancies receiving myelosuppressive anti-cancer drugs experienced pyrexia, pain, rash, cough, and dyspnea when compared with the placebo (≥ 5% difference in incidence compared to placebo). Furthermore, patients with AML experienced pain, epistaxis, and rash (≥ 2% difference in incidence). Patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT experienced rash (≥ 5% difference in incidence); and lastly, patients with severe chronic neutropenia experienced pain, anemia, epistaxis, diarrhea, hypoesthesia, and alopecia (≥ 5% difference in incidence).

Biosimilar Growth in the US Continues to Expand Access and Affordability Across Cancer Care

Filkri may be the first short-acting G-CSF for Accord BioPharma; filgrastim is the first drug to ever have an FDA-approved biosimilar. In 2015, filgrastim-sndz (Zarxio; Sandoz) was approved, paving the way for more than 67 biosimilars across 18 originators in the United States.2 Although filgrastim-sndz is a European biosimilar and is approved for hematopoietic stem and progenitor cell mobilization, its presence in the biosimilar space has made a significant impact.3

As pharmaceutical companies continue to realize the value of biosimilars for patients and health care systems, they are expanding access and affordability throughout the oncology, rheumatology, immunology, and supportive care spaces.2

“This approval of FILKRI demonstrates our steadfast dedication to expanding access to cost-effective biologic treatments in the critically important field of oncology,” Binish Chudgar, chairman and managing director of Intas Pharmaceuticals, said in a press release.1 “We're proud to have one of the largest biosimilar pipelines within the industry. With Accord BioPharma, we're positioning ourselves as a dependable partner in the United States—one that's deeply committed to understanding stakeholder priorities and revolutionizing patient access.”

References:

1. FDA approves FILKRITM (Filgrastim-Laha), Accord BioPharma’s biosimilar to NEUPOGEN (filgrastim). News release. PR Newswire. February 17, 2026. Accessed February 18, 2026. https://www.prnewswire.com/news-releases/fda-approves-filkri-filgrastim-laha-accord-biopharmas-biosimilar-to-neupogen-filgrastim-302689073.html

2. Jeremias S. Ten years of data support safety of biosimilar filgrastim for donor mobilization. Center for Biosimilars. August 22, 2025. Accessed February 18, 2026. https://www.centerforbiosimilars.com/view/ten-years-of-data-support-safety-of-biosimilar-filgrastim-for-donor-mobilization

3. Jeremias S. From Amjevita to Zarxio: a decade of US biosimilar approvals. Center for Biosimilars. March 6, 2025. Accessed February 18, 2026. https://www.centerforbiosimilars.com/view/from-amjevita-to-zarxio-a-decade-of-us-biosimilar-approvals