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Biosimilars referencing Amgen’s Neulasta and Neupogen launch in Canada and US

Biosimilars/News | Posted 21/11/2025 0 Post your comment

In September 2025, Kashiv BioSciences launched Pexegra (pegfilgrastim), a biosimilar referencing Amgen’s Neulasta, and Filra (filgrastim), a biosimilar referencing Amgen’s Neupogen, in the Canadian market. Additionally, Tanvex Biopharma announced its biosimilar drug Nypozi (filgrastim) is now available in the US market through marketing partner Cipla.

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It stimulates the production of white blood cells (neutrophils). Pegfilgrastim treatment is used to encourage bone marrow to produce more neutrophils to help fight infection in patients undergoing chemotherapy [1].

The launch of Pexegra in Canada comes after the product was granted marketing authorization in February 2025 [2]. Pexegra is a long-acting G-CSF biosimilar indicated for reducing incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies undergoing myelosuppressive antineoplastic therapy.

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment [3].

Kashiv BioSciences have now launched Filra in Canada and Pexegra and Filra biosimilars will be marketed through an exclusive agreement with JAMP Pharma Corporation.

After the product was approved in June 2024 [4], Tanvex Biopharma is now the first Taiwanese company to launch a biosimilar product to the US market. Under its contract with Cipla, Tanvex will be responsible for mass production and supply and will share in revenue and royalties with the marketing partner. This product has also been approved in Canada [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 21]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves pegfilgrastim biosimilar Pexegra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 21]. Available from: www.gabionline.net/biosimilars/news/canada-approves-pegfilgrastim-biosimilar-pexegra
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 20]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves filgrastim biosimilar Nypozi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 20]. Available from: www.gabionline.net/biosimilars/news/fda-approves-filgrastim-biosimilar-nypozi
5. GaBI Online - Generics and Biosimilars Initiative. Canada approves filgrastim biosimilar Nypozi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 20]. Available from: www.gabionline.net/biosimilars/news/canada-approves-filgrastim-biosimilar-nypozi

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