Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nypozi (TX01). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.
Nypozi is a biosimilar of Amgen’s Neupogen (filgrastim). 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.
Nypozi was developed by Taiwan-based biosimilars maker Tanvex Biopharma (Tanvex). The application for approval was submitted to Health Canada back in January 2019 [1] and the biosimilar was approved on 8 October 2021 as a solution for both intravenous and subcutaneous injection at doses of 300 μg/0.5 mL and 480 μg/0.8 mL.
There are already two other filgrastim biosimilars approved in Canada. Apotex’s Grastofil was the first to be approved in December 2015, followed by Pfizer’s Nivestym in April 2020 [2].
The approval of Nypozi marks the first biosimilar from Tanvex to be approved in Canada.
The company had also submitted an application for approval of its candidate filgrastim biosimilar (TX01) to the US Food and Drug Administration in October 2018, but this was rejected in September 2019 [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Tanvex BioPharma submits filgrastim biosimilar to Health Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/biosimilars/news/Tanvex-BioPharma-submits-filgrastim-biosimilar-to-Health-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim
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