Canada approves five adalimumab biosimilars in last six months

Biosimilares/Novedades | Posted 31/05/2021 post-comment0 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.

Canada V16A15

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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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

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

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Source: Amgen, Health Canada

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