Canada’s drug regulator, Health Canada, has approved the adalimumab biosimilars Simlandi (AVT02) and Yuflyma (CT-P17).
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.
Both Simlandi and Yuflyma are high-concentration, citrate-free biosimilars to Humira, which is used to treat a range of certain inflammatory conditions.
Simlandi is a result of the collaboration between Iceland-based biosimilars maker Alvotech and Canada-base pharmaceutical company JAMP Pharma Group (JAMP). The two companies signed an exclusive agreement to collaborate on a broad portfolio of biosimilars in January 2020 [1].
Simlandi was approved on 5 January 2022 as a high-concentration biosimilar to Humira at doses of 40 mg/0.4 mL and 80 mg/0.8 mL. Health Canada has also ruled that the 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject to the 24-month statutory stay pursuant to the Patented Medicines (Notice of Compliance) Regulations because AbbVie Corporation, the marketer of Humira, elected to not market the equivalent high-concentration versions to Canadian patients. This clears the way for JAMP to launch Simlandi in the Canadian market.
Yuflyma is produced by South Korean biotechnology company Celltrion. It was approved on 24 December 2021 as a high-concentration biosimilar to Humira at a dose of 100 mg/mL.
This is the first biosimilar approval in Canada for JAMP. For Celltrion, on the other hand, this marks the fifth biosimilar approval. The company has already received Canadian approval for trastuzumab (Herzuma), infliximab (Remsima and Remsima SC), and rituximab (Truxima) biosimilars. These latest approvals bring the total number of adalimumab biosimilars approved in Canada to nine [2].
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References
1. GaBI Online - Generics and Biosimilars Initiative. New biosimilars partnerships from Alvotech and Biocon biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/pharma-news/New-biosimilars-partnerships-from-Alvotech-and-Biocon
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-Canada
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Source: Alvotech, Health Canada
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