The BGTD regulates biologicals (products derived from living sources) and radiopharmaceuticals for human use in Canada, whether manufactured in Canada or elsewhere. Some of the products regulated by the BGTD include blood and blood products, haemostatic agents, bacterial and viral vaccines, hormones, enzymes, cytokines, monoclonal antibodies, allergenic extracts, gene and cell therapies, tissues and organs.

Health Canada, which is Canada’s federal department responsible for health, develops and enforces regulations under Canadian governmental legislation. The agency applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality.

In March 2010, Health Canada finalized guidelines for biosimilars, which were previously called subsequent entry biologics in Canada [1].

Health Canada defines biosimilars as a term used by the BGTD to describe a biological product that would be similar to and would enter the market subsequent to an approved innovator biological.

The first biosimilar to receive approval in Canada was Sandoz’s growth hormone treatment Omnitrope in 2009. To date, Health Canada has approved 27 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor (G-CSF), insulin, monoclonal antibodies and tumour necrosis factor (TNF)-inhibitor, for use in Canada, see Table 1.

Although Inflectra and Remsima are approved in Europe for Crohn’s disease and ulcerative colitis, extrapolation to these indications in Canada was not recommended due to differences between Inflectra/Remsima and the respective reference product. However, on 14 June 2016, Hospira announced that Health Canada had extended the approval of Inflectra to include Crohn’s disease, fistulising Crohn’s disease and ulcerative colitis [2].

Brenzys (SB4) was initially approved in Canada for the indications of ankylosing spondylitis and rheumatoid arthritis. The biosimilar is approved under the trade name Benepali (SB4, etanercept) in Europe, where it is also approved for the indications of axial spondyloarthritis and plaque psoriasis [3]. Extrapolation to these indications in Canada was not recommended. However, on 6 September 2020, Merck Canada announced that Brenzys had been approved for use in additional indications, including plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis [4].

Editor’s comment
Biosimilars approved in Canada have been authorized following a strict regulatory process in the same way as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals and also include a rigorous comparability exercise with the reference product.

Related article
Biosimilars approved in Europe

Biosimilars approved in Australia

References
1.  GaBI Online - Generics and Biosimilars Initiative. Canadian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 31]. Available from: www.gabionline.net/Guidelines/Canadian-guidelines-for-biosimilars
2.  GaBI Online - Generics and Biosimilars Initiative. Health Canada approves Inflectra biosimilar for extra indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 24]. Available from: www.gabionline.net/Biosimilars/News/Health-Canada-approves-Inflectra-biosimilar-for-extra-indications
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Indications expanded for Merck’s etanercept biosimilar Brenzys [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/News/Indications-expanded-for-Merck-s-etanercept-biosimilar-Brenzys 

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