Pegfilgrastim biosimilar Lapelga approved in Canada

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Pegfilgrastim biosimilar Lapelga approved in Canada

Biosimilares/Novedades | Posted 18/05/2018 0 Post your comment

Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision made on 5 April 2018. This marks the first pegfilgrastim biosimilar to be approved by the Canadian medicines regulator.

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.

Lapelga is a biosimilar of Amgen’s Neulasta (pegfilgrastim). It is indicated in Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs.

The positive decision was issued as the similarity of Lapelga to Neulasta has been established based on comparative analytical and functional, non-clinical, PK/PD and clinical studies, and clinically meaningful differences in safety and immunogenicity between Lapelga and Neulasta were observed. On the basis of these results, and considering the similarity demonstrated in comparative structural, functional, and non-clinical studies, the totality of data supports the authorization of Lapelga for the same indication as Neulasta.

Apotex’s first biosimilar, Grastofil (filgrastim), was approved by Health Canada in December 2015 for the treatment of neutropenia in adults and children receiving chemotherapy [1].

Lapelga is also currently under the US Food and Drug Administration review [2].

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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 2018 May 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review

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Source: Health Canada