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.

Fulphila (MYL‑1401H) has been approved by Health Canada, the country’s drug regulator, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Health Canada’s approval of Fulphila was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to the originator biological, Amgen’s Neulasta, and that there were no clinically meaningful differences in terms of safety and efficacy exist.

Fulphila (pegfilgrastim-jmdb) was also approved in the US, as the first pegfilgrastim biosimilar in the country, in June 2018 [1], with launch in July 2018. It was also approved in Europe in November 2018 [2] and was launched in Australia in early April 2020 [3].

Fulphila will be launched in Canada by Mylan. Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Their pegfilgrastim biosimilar is one of 11 biosimilars being co-developed by the pair for the global marketplace. Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has shared or co-exclusive commercialization rights with Mylan for the product in the rest of the world.

The pair also say that ‘a suite of patient services will be available at launch to further support patients and caregivers with treatment’.

Related articles
Biosimilars of pegfilgrastim

Biosimilars approved in Canada

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 8]. Available from: www.gabionline.net/Biosimilars/News/Biocon-Mylan-launch-pegfilgrastim-biosimilar-Fulphila-in-Australia

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