Canada’s drug regulator, Health Canada, has approved the infliximab biosimilar Remsima SC for the treatment of autoimmune diseases.
The drug 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.
Celltrion Healthcare’s Remsima SC was approved on 28 January 2021 as both a powder for solution for intravenous injection at a dose of 120 mg/syringe and as a solution for subcutaneous injection at a dose of 120 mg/mL.
This latest approval brings the total number of infliximab biosimilars approved in Canada up to five. Hospira’s Inflectra and Celltrion’s Remsima were approved by Health Canada in January 2014 and Renflexis, which is made by Samsung Bioepis, was approved in December 2017 [1]. Then, Amgen’s Avsola was approved by the Canadian drug regulator in March 2020 [2].
Celltrion says that ‘with the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option’. They add that ‘Remsima SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment’. The company has applied for patent protection, until 2038, for Remsima SC in approximately 100 countries throughout North America, Europe and Asia.
Celltrion also announced on 8 February 2021 that it had launched Remsima SC in Korea for at-home treatment of rheumatoid arthritis and inflammatory bowel disease.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/Canada-approves-infliximab-and-filgrastim-biosimilars-Avsola-and-Nivestym
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Source: Celltrion, Health Canada, Korea Herald
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