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Canada approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 02/07/2021 0 Post your comment

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nyvepria (PF-06881894). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Nyvepria 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.

Pfizer’s Nyvepria was approved on 18 January 2021 as a solution for subcutaneous injection at a dose of 6 mg/0.6 mL.

There are already three pegfilgrastim biosimilars approved in Canada. Apotex’s Lapelga was the first to be approved in April 2018, followed by Biocon/Mylan’s Fulphila in December 2018 and finally Sandoz’s Ziextenzo in April 2020 [1].

The approval of Nyvepria marks the second biosimilar from Pfizer to be approved in Canada. The company also has a filgrastim biosimilar, Nivestim, approved in the country [1].

Nyvepria also been approved in the US [2] and in Europe [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves pegfilgrastim biosimilar Nyvepria [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 2]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-pegfilgrastim-biosimilar-Nyvepria
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for pegfilgrastim biosimilar Nyvepria [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 2]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-pegfilgrastim-biosimilar-Nyvepria

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Source: Health Canada