Biosimilars approved in Canada

Biosimilars/General | Posted 31/01/2014 0 Post your comment

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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Source: Health Canada

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