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Canada approves five adalimumab biosimilars in last six months

Biosimilars/News | Posted 31/05/2021 0 Post your comment

Since October 2020, Canada’s drug regulator, Health Canada, has approved no less than five adalimumab biosimilars for the treatment of multiple chronic inflammatory diseases.

The drugs are biosimilars of AbbVie’s Humira (adalimumab). Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Fresenius Kabi’s Idacio (MSB11022) was approved on 30 October 2020. Both Sandoz’s Hyrimoz (GP2017) and Amgen’s Amgevita (ABP 501) were approved on 4 November 2020. Mylan’s Hulio (FKB327), which will be marketed in Canada by BGP Pharma, was approved on 24 November 2020. Pfizer’s Adalimumab Injection was approved on 14 January 2021.

All were approved as solutions for subcutaneous injection in dosages of 10 mg/0.2 mL (Adalimumab Injection), 20 mg/0.4 mL (Adalimumab Injection/Hyrimoz), 20 mg/syringe (Hulio), 40 mg/syringe (Adalimumab Injection/Amgevita/Hyrimoz/Hulio/ Idacio), 40 mg/pen (Hulio/Idacio), 40 mg/vial (Adalimumab Injection/Idacio), 40 mg/0.8 mL (Adalimumab Injection/ Amgevita/Hyrimoz) and 50 mg/mL (Amgevita).

These approvals bring the total adalimuab biosimilars approved in Canada up to six. Samsung Bioepis had its adalimumab biosimilar, Hadlima (SB5) approved by Health Canada in May 2018 [1].

Amgen announced on 4 May 2021 that it had launched Amgevita in Canada for the treatment of 11 chronic inflammatory conditions.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis launches Hadlima in Australia and Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 31]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-launches-Hadlima-in-Australia-and-Canada

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Source: Amgen, Health Canada