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Biosimilars approved in Canada Posted 31/01/2014

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.
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 12 Mar 2020 Amgen Brenzys etanercept
Ankylosing spondylitis 31 Aug 2016 Merck Canada/Samsung Bioepis Erelzi etanercept
Ankylosing spondylitis 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 3 Sep 2019 Celltrion Healthcare Inclunox enoxaparin
Deep vein thrombosis 5 Nov 2020 Sandoz Inflectra infliximab
Ankylosing spondylitis 15 Jan 2014 Hospira (Celltrion Healthcare) Kanjinti trastuzumab Breast cancer Oct 2020 Amgen Lapelga pegfilgrastim Neutropenia 5 Apr 2018 Apotex Mvasi bevacizumab
Colorectal cancer 30 Apr 2018 Amgen Nivestym filgrastim
Mobilization of autologous PBPCs 16 Apr 2020 Pfizer Noromby enoxaparin
Deep vein thrombosis 14 Oct 2020 Juno Pharmaceuticals Omnitrope somatropin
Growth hormone deficiency 20 Apr 2009 Sandoz Osnuvo teriparatide Osteoporosis 13 Jan 2020 Avir Pharma Redesca enoxaparin
Deep vein thrombosis 7 Dec 2020 Shenzen Techdow Pharmaceutical Remsima infliximab
Ankylosing spondylitis 15 Jan 2014 Celltrion Healthcare Remsima SC infliximab
Ankylosing spondylitis 28 Jan 2021 Celltrion Healthcare Renflexis infliximab
Ankylosing spondylitis 1 Dec 2017 Samsung Bioepis Riximyo rituximab
Chronic lymphocytic leukemia 28 Apr 2020 Sandoz Ruxience rituximab
Chronic lymphocytic leukemia 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 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
Related article Biosimilars approved in Australia
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Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Juvenile idiopathic arthritis##
Psoriatic arthritis##
Psoriasis##
Rheumatoid arthritis
Juvenile idiopathic arthritis
Rheumatoid arthritis
Psoriaritic arthritis
Metastatic breast cancer
Metastatic gastric cancer
Pulmonary embolism
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Glioblastoma
NSCLC
Ovarian cancer
Neutropenia
Pulmonary embolism
Idiopathic short stature
Small for gestational age
Turner syndrome
Pulmonary embolism
Crohn's disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Crohn's disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Non-Hodgkin lymphoma
Rheumatoid arthritis
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin lymphoma
Rheumatoid arthritis
**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
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.
Biosimilars approved in Europe
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
Source: Health Canada
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