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Subsequent entry biologics approved in Canada Posted 31/01/2014

Last update: 8 September 2017

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 subsequent entry biologics (SEBs) [1].

Health Canada defines SEB 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 SEB to receive approval in Canada was Sandoz’s growth hormone treatment Omnitrope in 2009. To date, Health Canada has approved six SEBs within the product classes of human growth hormone, granulocyte colony-stimulating factor (G-CSF) and tumour necrosis factor (TNF)-inhibitor, for use in Canada, see Table 1.

Table 1: Health Canada approved subsequent entry biologics*

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/ Company name

Brenzys

etanercept

Ankylosing spondylitis
Rheumatoid arthritis

31 Aug 2016

Merck Canada

Erelzi

etanercept

Ankylosing spondylitis
Juvenile idiopathic arthritis
Rheumatoid arthritis

3 Aug 2017

Sandoz

Grastofil

filgrastim

Neutropenia 

7 Dec 2015

Apotex

Inflectra

infliximab

Ankylosing spondylitis
Crohn’s disease#
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis#

15 Jan 2014

Hospira

Omnitrope

somatropin

Growth hormone deficiency in adults and children

20 Apr 2009

Sandoz

Remsima

infliximab

Ankylosing spondylitis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis

15 Jan 2014

Celltrion

*Data collected on 23 January 2014, updated on 8 September 2017.
#Added to approved indications on 14 June 2016
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 [4].

Brenzys (SB4) 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.

Editor’s comment
Subsequent entry biologics 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

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Source: Health Canada

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