Biosimilars approved in Canada

Biosimilares/General | Posted 31/01/2014 post-comment0 Post your comment

Last update: 19 February 2021

In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

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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.

Table 1: Health Canada approved biosimilars*
Product name Active substance Therapeutic area Authorization date** Manufacturer/ Company name
Apo-teriparatide teriparatide Osteoporosis 8 May 2020 Apotex
Avsola infliximab Ankylosing spondylitis
Crohn’s disease 
Psoriatic arthritis 
Psoriasis
Rheumatoid arthritis 
Ulcerative colitis
12 Mar 2020 Amgen
Brenzys etanercept Ankylosing spondylitis
Juvenile idiopathic arthritis##
Psoriatic arthritis##
Psoriasis##
Rheumatoid arthritis 
31 Aug 2016 Merck Canada/ Samsung Bioepis
Erelzi etanercept Ankylosing spondylitis
Juvenile idiopathic arthritis
Rheumatoid arthritis
Psoriaritic arthritis
3 Aug 2017 Sandoz
Fulphila  pegfilgrastim Neutropenia 24 Dec 2018 BGP Pharma (Biocon/Mylan)
Grastofil filgrastim Neutropenia  7 Dec 2015 Apotex
Hadlima adalimumab Rheumatoid arthritis 8 May 2018 Samsung Bioepis
Herzuma trastuzumab Early breast cancer cancer
Metastatic breast cancer
Metastatic gastric cancer
3 Sep 2019 Celltrion Healthcare
Inclunox enoxaparin Deep vein thrombosis
Pulmonary embolism
5 Nov 2020 Sandoz
Inflectra infliximab Ankylosing spondylitis
Crohn’s disease 
Psoriatic arthritis 
Psoriasis
Rheumatoid arthritis 
Ulcerative colitis
15 Jan 2014 Hospira (Celltrion Healthcare)
Kanjinti trastuzumab Breast cancer  Oct 2020 Amgen
Lapelga pegfilgrastim Neutropenia 5 Apr 2018 Apotex
Mvasi bevacizumab Colorectal cancer
Glioblastoma
NSCLC
Ovarian cancer
30 Apr 2018 Amgen
Nivestym filgrastim Mobilization of autologous PBPCs
Neutropenia 
16 Apr 2020 Pfizer
Noromby enoxaparin Deep vein thrombosis
Pulmonary embolism
14 Oct 2020 Juno Pharmaceuticals
Omnitrope somatropin Growth hormone deficiency
Idiopathic short stature
Small for gestational age
Turner syndrome
20 Apr 2009 Sandoz
Osnuvo teriparatide Osteoporosis 13 Jan 2020 Avir Pharma
Redesca enoxaparin Deep vein thrombosis
Pulmonary embolism
7 Dec 2020 Shenzen Techdow Pharmaceutical
Remsima infliximab Ankylosing spondylitis
Crohn's disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
15 Jan 2014 Celltrion Healthcare
Remsima SC infliximab Ankylosing spondylitis
Crohn’s disease 
Psoriatic arthritis 
Psoriasis
Rheumatoid arthritis 
Ulcerative colitis
28 Jan 2021 Celltrion Healthcare
Renflexis infliximab Ankylosing spondylitis
Crohn's disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
1 Dec 2017 Samsung Bioepis
Riximyo rituximab Chronic lymphocytic leukemia
Non-Hodgkin lymphoma
Rheumatoid arthritis
28 Apr 2020 Sandoz
Ruxience rituximab Chronic lymphocytic leukemia
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin lymphoma
Rheumatoid arthritis 
4 May 2020 Pfizer
Teva-teriparatide teriparatide Osteoporosis 19 Jun 2020 Teva Pharmaceutical Industries
Trurapi insulin aspart Diabetes 15 Oct 2020 Sanofi-Aventis
Ziextenzo pegfilgrastim Neutropenia 21 Apr 2020 Sandoz
*Data updated on 19 February 2021
**Date of first Notice of Compliance from Health Canada
#Added to approved indications on 14 June 2016
##Added to approved indications on 19 August 2020
NSCLC: Non-squamous non-small cell lung cancer; PBPC: peripheral blood progenitor cell.
Source: Health Canada

  
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 articles
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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Source: Health Canada

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