Canada approves pegfilgrastim biosimilar Ziextenzo

Biosimilars/News | Posted 26/06/2020 post-comment0 Post your comment

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.

Pegfilgrastim V16B19

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: Health Canada

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010