Canada approves five biosimilars in last seven months

Biosimilars/News | Posted 03/06/2022 post-comment0 Post your comment

Since November 2021, Canada’s drug regulator, Health Canada, has approved no less than five biosimilars for the treatment of diabetes, cancer, osteoporosis and autoimmune conditions.

Health Canada V13I20

The drugs are biosimilars of Roche’s Avastin (bevacizumab), Johnson & Johnson and Merck’s Remicade (infliximab), Sanofi’s Lantus (insulin glargine), Eli Lilly’s Forteo/Forsteo (teriparatide) and Roche’s Herceptin (trastuzumab).

Two bevacizumab biosimilars were approved in the last seven months. BGP Pharma will market Biocon/Mylan’s Abevmy (MYL 1402O), which was approved on 5 November 2021. Then Aybinto (SB8), which is produced by Samsung Bioepis, was approved on 20 November 2021. Both were approved as solutions for intravenous use in dosages of 100 mg/vial and 400 mg/vial. Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Pfizer’s infliximab biosimilar Ixifi (PF 06438179) was approved on 21 December 2021. It was approved as a powder for solution to be given intravenously at doses of 100 mg/vial. 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.

The trastuzumab biosimilar Ontruzant (SB3), which is produced by Samsung Bioepis, was approved on 28 January 2022. The biosimilar was approved as a powder for solution to be given intravenously at doses of 440 mg/vial. Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers.

Finally, Biocon/Mylan’s insulin glargine biosimilar Semglee (MYL‑1501D) which was approved by Health Canada on 8 April 2022 will be marketed by Canada’s BGP Pharma. The biosimilar has been approved as a solution for subcutaneous injection at a dose of 100 unit/mL. Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

These approvals bring the total number of biosimilars approved in Canada up to 50 [1].

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Biosimilars of bevacizumab

Biosimilars approved in Canada


The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 3]. Available from:

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Source: Health Canada

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