In September 2025, Kashiv BioSciences launched two biosimilars in Canada: Pexegra (pegfilgrastim), referencing Neulasta, and Filra (filgrastim), referencing Neupogen. Both products will be marketed through an exclusive agreement with JAMP Pharma Corporation.

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 (6 mg/0.6 mL pre-filled syringe) follows its marketing authorization in February 2025 [2]. As a long-acting granulocyte colony-stimulating factor (G-CSF), it is indicated to reduce the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy.

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]. 

Similarly, Filra received Health Canada approval and a Notice of Compliance for JAMP Pharma on 24 March 2025. The biosimilar is indicated for cancer patients to manage neutropenia during various treatments, including myelosuppressive, myeloablative, and peripheral blood progenitor cell (PBPC) transplantation therapies. It is also used for patients with acute myeloid leukemia and severe chronic neutropenia. Available in 300 mcg/0.5 mL and 480 mcg/0.8 mL pre-filled syringes, it was launched concurrently with Pexegra the following September.

In a parallel development, Tanvex Biopharma has launched its filgrastim biosimilar, Nypozi (filgrastim-txid), in the US market through marketing partner Cipla. Approved in June 2024 [4], this launch makes Tanvex the first Taiwanese company to commercialize a biosimilar in the US. Under the contract, Tanvex will handle mass production and supply, sharing revenue and royalties with Cipla. Nypozi has also received approval in Canada [5].

Related article
Clinical trial advances for Kashiv and Celltrion

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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