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Canada approves pegfilgrastim biosimilar Armlupeg

Biosimilars/News | Posted 20/11/2024 0 Post your comment

India-based Lupin Limited (Lupin) announced on 23 August 2024 that it received marketing approval from Health Canada for its biosimilar pegfilgrastim biosimilar, which will be marketed as Armlupeg.

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. The originator product is Amgen’s Neulasta [1].

Armlupeg is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Armlupeg will be manufactured at Lupin’s biotech facility at Pune, India, and will be available in a pre-filled syringe form (6 mg/0.6 mL).

This is not the first biosimilar produced by Lupin to be approved in Canada. In 2022, etanercept biosimilar Rymti (etanercept), received Health Canada’s approval for all indications of the reference product Enbrel [2].

By October 2024, in addition to Armlupeg, Health Canada has approved four pegfilgrastim biosimilar, as shown in Table 1.

Table 1: Pegfilgrastim biosimilars approved in Canada

Product name	Authorization date*	Manufacturer/Company name
Armlupeg	23 August 2024	Lupin
Fulphila	24 Dec 2018	BGP Pharma (Biocon/Mylan)
Lapelga	5 Apr 2018	Apotex
Nyvepria	18 Jan 2021	Pfizer
Ziextenzo	21 Apr 2020	Sandoz
*Data updated 20 November 2024

Canada approves pegfilgrastim biosimilar Nyvepria

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 20]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves etanercept biosimilar Rymti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 20]. Available from: www.gabionline.net/biosimilars/news/canada-approves-etanercept-biosimilar-rymti

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