On 25 February 2025, Health Canada granted marketing authorization to India-based Kashiv BioSciences for its pegfilgrastim biosimilar, Pexegra, which references Amgen’s Neulasta (pegfilgrastim).
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].
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.
The marketing authorization was granted following a rigorous regulatory review by Health Canada, ensuring that Kashiv’s pegfilgrastim Injection meets the stringent quality, safety, and efficacy standards comparable to the reference biological.
Pexegra will be distributed and commercialised in Canada by Kashiv’s licensing partner, Jamp Pharma Group.
Kashiv has already received regulatory success with its filgrastim biosimilar Releuko (filgrastim-ayow), which was approved by the US Food and Drug Administration in March 2022 [2].
Additionally, Kashiv completed a global phase I clinical study in healthy volunteers for its biosimilar candidate, ADL018, referencing Xolair (omalizumab), in late 2023 [3].
In a related development, India-based Lupin received marketing approval from Health Canada for its biosimilar pegfilgrastim, Armlupeg, on 23 August 2024 [4].
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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 Mar 21]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves Kashiv Biosciences’ filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 21]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-kashiv-biosciences-filgrastim-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Clinical trial advances for Kashiv and Celltrion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 21]. Available from: www.gabionline.net/biosimilars/research/clinical-trial-advances-for-kashiv-and-celltrion
4. GaBI Online - Generics and Biosimilars Initiative. Canada approves pegfilgrastim biosimilar Armlupeg [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 21]. Available from:
www.gabionline.net/biosimilars/research/clinical-trial-advances-for-kashiv-and-celltrion
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