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Canada approves pegfilgrastim biosimilar Ziextenzo Posted 26/06/2020

Canada’s drug regulator, Health Canada, has approved the pegfilgrastim biosimilar Ziextenzo (LA-EP2006). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

The drug is a biosimilar of Amgen’s Neulasta (pegfilgrastim). Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Sandoz’s Ziextenzo was approved on 21 April 2020 as a solution for subcutaneous injection at a dose of 6 mg/0.6 mL.

Sandoz, in its press release, quotes statistics published by the Canadian Cancer Society, which that report that in 2019 an estimated 21,000 Canadians received a blood cancer diagnosis. This makes up approximately 10% of all cancer diagnoses and includes non-Hodgkin’s lymphoma (10,000) and leukaemia (6,700). In addition, although survival rates for blood cancers have increased over the years, they still caused the deaths of 7,200 Canadians in 2016, according to a report released by The Leukemia & Lymphoma Society of Canada.

Ziextenzo is the second pegfilgrastim biosimilar to be approved in Canada. Biocon/Mylan’s Fulphila (MYL-1401H) was the first to be approved in the country on 24 December 2019. Fulphila is being distributed in Canada by BGP Pharma.

Sandoz has three other biosimilars approved in Canada. Omnitrope (somatropin) was approved by Health Canada in April 2009 [1], Erelzi (etanercept) in August 2017 [1] and Riximyo (rituximab) in April 2020 [2].

Ziextenzo has also been approved in both the US [3] and Europe [4].

Related article
Biosimilars of pegfilgrastim

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves rituximab biosimilars Riximyo and Ruxience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 26]. Available from: www.gabionline.net/Biosimilars/News/Canada-approves-rituximab-biosimilars-Riximyo-and-Ruxience
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Health Canada

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