Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.
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.
Kirsty is a biosimilar of Novo Nordisk’s NovoLog (insulin aspart). Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset and a shorter duration of activity than normal human insulins.
Nypozi (TX-01) is produced by Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) and was submitted to Health Canada for approval back in January 2019 [1]. The biosimilar filgrastim 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.
Kirsty is produced by India-based BioGeneric Pharma (BGP Pharma) The biosimilar insulin aspart was approved by Health Canada on 12 October 2021 as a solution for subcutaneous injection at a dose of 100 units/mL.
There are already two other filgrastim biosimilars and one other insulin aspart biosimilar approved in Canada [2]. BGP Pharma has also received approval in Canada for its adalimumab (Hulio), pegfilgrastim (Fulphila) and trastuzumab (Ogivri) biosimilars [2]. This is Tanvex’s first biosimilar approval in Canada. Tanvex also submitted an application for its proposed filgrastim biosimilar (TX 01) to the US Food and Drug Administration in December 2018 [1]. However, this was rejected in September 2019 [3].
Source: Health Canada, Taipei Times
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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 2021 Nov 12]. 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 2021 Nov 12]. 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 2021 Nov 12]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim
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