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Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym Posted 10/07/2020

Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.

Avsola is a biosimilar of Johnson & Johnson and Merck’s Remicade (infliximab). Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Nivestym is a biosimilar of Amgen’s Neupogen (filgrastim). Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

Amgen’s Avsola was approved on 12 March 2020 as a powder for solution for intravenous injection at a dose of 100 mg/vial. Pfizer’s Nivestym was approved on 16 April 2020 as a solution for both intravenous use and subcutaneous injection at doses of 300 µg/mL, 300 µg/0.5 mL, 480 µg/1.5 mL and 480 µg/0.8 mL.

There are already both infliximab and filgrastim biosimilars approved in Canada [1]. Amgen has also a bevacizumab biosimilar, Mvasi, approved in Canada and Pfizer (through its Hospira subsidiary) has another infliximab biosimilar, Inflectra, approved in the country [1].

Avsola and Nivestym have both also been approved in the US [2, 3] and Nivestym has also been approved in Europe [4].

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Biosimilars of filgrastim

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s infliximab biosimilar Avsola [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-infliximab-biosimilar-Avsola
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves filgrastim biosimilar Nivestym [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-filgrastim-biosimilar-Nivestym
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Health Canada

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