Accord BioPharma, the United States specialty division of Intas Pharmaceuticals Ltd., announced that the US Food and Drug Administration has approved FILKRI filgrastim laha, a biosimilar referencing NEUPOGEN filgrastim. The therapy is approved for patients with cancer who are receiving myelosuppressive chemotherapy, individuals with acute myeloid leukemia undergoing induction or consolidation treatment, patients receiving bone marrow transplantation, those living with severe chronic neutropenia, and individuals exposed to myelosuppressive levels of radiation associated with hematopoietic syndrome.
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The approval expands Accord BioPharma’s biosimilar portfolio and strengthens its position in oncology supportive care. FILKRI becomes the company’s sixth FDA approved biosimilar and adds to a growing lineup that includes UDENYCA pegfilgrastim cbqv, a biosimilar referencing Neulasta pegfilgrastim. With both short acting and long acting granulocyte colony stimulating factor options now available, Accord offers providers flexibility when selecting treatment approaches for neutropenia management across different care settings.
The company has applied for a permanent Q code from the Centers for Medicare and Medicaid Services, which would support consistent billing and reimbursement processes in hospital outpatient departments, ambulatory surgery centers, and physician offices.
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Neutropenia remains one of the most common complications associated with cancer therapy. When neutrophil levels fall below normal, patients face a higher risk of infection that can interrupt treatment plans or require dose reductions. Granulocyte colony stimulating factors help stimulate the production of neutrophils in the bone marrow, shortening the duration of neutropenia and lowering infection risk. FILKRI is produced using recombinant DNA technology and functions by promoting neutrophil development.
Chrys Kokino, President of Accord North America, said that treatment related neutropenia can significantly affect outcomes for cancer patients. He explained that by offering both FILKRI and UDENYCA, Accord is equipping healthcare providers with a complete range of G CSF biosimilar options, reinforcing the company’s role in supporting oncology practices and expanding patient access to biologic therapies.
The FDA based its approval on randomized clinical studies conducted in healthy adults that compared pharmacokinetics, pharmacodynamics, safety, and immunogenicity between FILKRI and the reference product. Results demonstrated comparable clinical performance and a similar safety profile. FILKRI is not recommended for patients with a history of serious allergic reactions to filgrastim or pegfilgrastim products.
Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals, said the approval reflects the organization’s long term commitment to increasing access to affordable biologic treatments in oncology. He noted that with one of the industry’s largest biosimilar pipelines and a goal of launching 20 biosimilars in the United States by 2030, Accord BioPharma aims to serve as a dependable partner focused on stakeholder needs and improved patient access.
Accord BioPharma’s current commercial portfolio also includes IMULDOSA ustekinumab srlf, HERCESSI trastuzumab strf, and CAMCEVI leuprolide 42 mg injectable emulsion, along with additional recently approved products that are expected to launch in the near future.
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