On 15 January 2026, the US Food and Drug Administration (FDA) approved the first biosimilar of the year, Accord Biopharma’s Filkri (filgrastim-laha), a biosimilar to Amgen’s Neupogen (filgrastim).
Filgrastim is a granulocyte colony-stimulating factor (G-CSF). It is used to stimulate the bone marrow to produce more neutrophils–a type of white blood cells that helps fight infection–in patients undergoing chemotherapy for cancer treatment [1].
The approval was supported by two randomized studies in healthy adults. One study assessed pharmacokinetics (PK)/pharmacodynamics (PD), while both evaluated safety and immunogenicity in comparison with reference product, Neupogen. These studies demonstrated the biosimilarity in PK and PD parameters between Filkri (filgrastim-laha) and Neupogen; and showed comparable safety and immunogenicity profiles. Filkri (filgrastim-laha) is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim products or pegfilgrastim products.
Filkri (filgrastim-laha) is approved for use in:
- 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
- individuals acutely exposed to myelosuppressive doses of radiation (for the haematopoietic syndrome of acute radiation syndrome).
The product is available in 300 mcg/0.5 mL and 480 mcg/0.8 mL single-dose prefilled syringes for subcutaneous (SC) or intravenous (IV) use.
With this approval, Filkri (filgrastim-laha) becomes the sixth biosimilar in Accord BioPharma's FDA-approved portfolio, which also includes Udenyca (pegfilgrastim-cbqv), Osvyrti and Jubereq (denosumab-desu) [2], Imuldosa (ustekinumab-srlf) [3], and Hercessi (trastuzumab-strf) [4].
Accord Biopharma is the US specialty division of Intas Pharmaceuticals, focusing on the development of oncology, immunology, and critical care therapies.
There were no biosimilars approved by the FDA in February 2026.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 23]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-denosumab-biosimilars-osvyrti-and-jubereq-boncresa-and-oziltus
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves fifth ustekinumab biosimilar Imuldosa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-fifth-ustekinumab-biosimilar-imuldosa
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves second strength of trastuzumab biosimilar Hercessi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-second-strength-of-trastuzumab-biosimilar-hercessi
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