Last update: 6 August 2024
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 59 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.
In the Health Canada approval of biosimilars, denosumab was approved under two brand names – Jubbonti and Wyost – by Sandoz on 20 February and 4 March 2024, respectively.
| Table 1: Health Canada approved biosimilars*
|
| Product name
|
Active substance
|
Therapeutic area
|
Authorization date**
|
Manufacturer/ Company name
|
| Abevmy
|
bevacizumab
|
Brain cancer
Lung cancer
Ovarian cancer
|
5 Nov 2021
|
BGP Pharma (Biocon/Mylan)
|
| Abrilada
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
29 Jun 2021
|
Pfizer
|
| Admelog
|
insulin lispro
|
Diabetes
|
16 Nov 2017
|
Sanofi-aventis
|
| Amgevita
|
adalimumab
|
Rheumatoid arthritis
|
4 Nov 2020
|
Amgen
|
| 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
|
| Axberi, Axberi HP
|
enoxaparin sodium
|
Antithrombotic agent
|
27 Jul 2023
|
Baxter
|
| Aybinto
|
bevacizumab
|
Brain cancer
Lung cancer
Ovarian cancer
|
20 Nov 2021
|
Samsung Bioepis
|
| Bambevi
|
|
Brain cancer
Lung cancer
Ovarian cancer
|
23 Sep 2021
|
Apotex
|
| Basaglar
|
insulin glargine
|
Diabetes
|
1 Sep 2015
|
Eli Lilly
|
| Brenzys
|
etanercept
|
Ankylosing spondylitis
Juvenile idiopathic arthritis##
Psoriatic arthritis##
Psoriasis##
Rheumatoid arthritis
|
31 Aug 2016
|
Merck Canada/ Samsung Bioepis
|
| Byooviz
|
ranibizumab
|
Choroidal neovascularization
Diabetic macular edema
Macular edema
Wet AMD
|
8 Mar 2022
|
Samsung Bioepis/ Biocon
|
| Elonox, Elonox HP
|
enoxaparin sodium
|
deep vein thrombosis
|
26 Oct 2022
|
Fresenius Kabi
|
| 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
|
| Hulio
|
adalimumab
|
Rheumatoid arthritis
|
24 Nov 2020
|
BGP Pharma/ Mylan
|
| Hyrimoz
|
adalimumab
|
Rheumatoid arthritis
|
4 Nov 2020
|
Sandoz
|
| Idacio
|
adalimumab
|
Rheumatoid arthritis
|
30 Oct 2020
|
Fresenius Kabi
|
| Inclunox, Inclunox HP
|
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)
|
| Ixifi
|
infliximab
|
Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
21 Dec 2021
|
BGP Pharma (Biocon/Mylan)
|
| Jamteki
|
ustekinumab
|
Psoriasis
Psoriatic arthritis
|
23 Nov 2023
|
JAMP Pharma
|
| Jubbonti
|
denosumab
|
Postmenopausal osteoporosis
Osteoporosis in men
Breast cancer treatment–induced bone loss
Prostate cancer treatment–induced bone loss
Glucocorticoid-induced osteoporosis
|
20 Feb 2024
|
Sandoz
|
| Kanjinti
|
trastuzumab
|
Breast cancer
|
27 Feb 2020
|
Amgen
|
| Kirsty
|
insulin aspart
|
Diabetes
|
14 Oct 2021
|
BGP Pharma
|
| Lapelga
|
pegfilgrastim
|
Neutropenia
|
5 Apr 2018
|
Apotex
|
| Mvasi
|
bevacizumab
|
Colorectal cancer
Glioblastoma
NSCLC
Ovarian cancer
|
30 Apr 2018
|
Amgen
|
| Myxredlin
|
insulin human
|
diabetes mellitus
|
3 Aug 2022
|
Baxter
|
| Nivestym
|
filgrastim
|
Mobilization of autologous PBPCs
Neutropenia
|
16 Apr 2020
|
Pfizer
|
| Noromby, Noromby HP
|
enoxaparin
|
Deep vein thrombosis
Myocardial infarction
Prevention of thrombus formation during hemodialysis
Pulmonary embolism
Unstable angina
|
14 Oct 2020
|
Juno Pharmaceuticals
|
| Nypozi
|
filgrastim
|
Neutropenia
|
8 Oct 2021
|
Tanvex Biopharma
|
| Nyvepria
|
pegfilgrastim
|
Neutropenia
|
18 Jan 2021
|
Pfizer
|
| Ogivri
|
trastuzumab
|
Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer
|
6 Jun 2019
|
BGP Pharma (Biocon/Mylan)
|
| Omnitrope
|
somatropin
|
Growth hormone deficiency
Idiopathic short stature
Small for gestational age
Turner syndrome
|
20 Apr 2009
|
Sandoz
|
| Ontruzant
|
trastuzumab
|
Breast cancer
|
28 Jan 2022
|
Samsung Bioepis
|
| Osnuvo
|
teriparatide
|
Osteoporosis
|
13 Jan 2020
|
Avir Pharma
|
| Ranopto
|
ranibizumab
|
Choroidal neovascularization (CNV)
Diabetic macular oedema (DME)
Retinal vein occlusion (RVO)
Wet macular degeneration (nAMD)
|
11 Oct 2023
|
Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada
|
| Redesca, Redesca HP
|
enoxaparin
|
Deep vein thrombosis
Myocardial infarction
Prevention of thrombus formation during hemodialysis
Pulmonary embolism
Unstable angina
|
7 Dec 2020
|
Shenzen Techdow Pharmaceutical/Valeo Pharma
|
| Remsima Remsima SC
|
infliximab
|
Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
15 Jan 2014
28 Jan 2021
|
Celltrion Healthcare
|
| Renflexis
|
infliximab
|
Ankylosing spondylitis
Crohn's disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
|
1 Dec 2017
|
Samsung Bioepis
|
| Riabni
|
rituximab
|
Chronic lymphocytic leukemia
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin lymphoma
Rheumatoid arthritis
|
11 Mar 2021
|
Amgen
|
| 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
|
| Rymti
|
etanercept
|
Axial spondyloarthritis
Juvenile idiopathic arthritis
Paediatric plaque psoriasis
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
|
13 Sep 2022
|
Lupin Biotech
|
| Semglee
|
insulin glargine
|
Diabetes
|
8 Apr 2022
|
BGP Pharma (Biocon/Mylan)
|
| Simlandi
|
adalimumab
|
Rheumatoid arthritis
|
5 Jan 2022
|
JAMP Pharma
|
| Teva-teriparatide
|
teriparatide
|
Osteoporosis
|
19 Jun 2020
|
Teva Pharmaceutical Industries
|
| Trazimera
|
trastuzumab
|
Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer
|
22 Oct 2019
|
Pfizer
|
| Trurapi
|
insulin aspart
|
Diabetes
|
15 Oct 2020
|
Sanofi-Aventis
|
| Truxima
|
rituximab
|
Chronic lymphocytic leukemia
Non-Hodgkin lymphoma
Rheumatoid arthritis
|
4 Apr 2019
|
Celltrion Healthcare
|
| Vegzelma
|
bevacizumab
|
Epithelial ovarian cancer
Fallopian tube cancer
Glioblastoma
Metastatic colorectal cancer
Non-small cell lung cancer
Primary peritoneal cancer
|
3 Jan 2023
|
Celltrion Healthcare
|
| Wezlana
|
ustekinumab
|
Crohn’s disease
Plaque psoriasis (adult and paediatric)
Psoriatic arthritis
Ulcerative colitis
|
27 Dec 2023
|
Amgen
|
| Wyost
|
denosumab
|
Prevention of skeletal-related events in patients with bone metastases from solid tumors
Giant cell tumor of bone
|
4 Mar 2024
|
Sandoz
|
| Yesafili
|
aflibercept
|
Central/Branch retinal vein occlusion
Diabetic macular oedema
Myopic choroidal neovascularization
Neovascular age-related macular degeneration
|
Mar 2023
|
Biocon
|
| Yuflyma
|
adalimumab
|
Rheumatoid arthritis
|
24 Dec 2021
|
Celltrion Healthcare
|
| Ziextenzo
|
pegfilgrastim
|
Neutropenia
|
21 Apr 2020
|
Sandoz
|
| Zirabev
|
bevacizumab
|
Colorectal cancer
Fallopian tube cancer
Glioblastoma
NSCLC
Primary peritoneal cancer
Ovarian cancer
|
5 Jan 2021
|
Pfizer
|
*Data updated on 6 August 2024
**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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