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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
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 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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Source: Health Canada

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