Canada’s federal department responsible for health, Health Canada, finalized guidelines for biosimilars, or subsequent entry biologics (SEBs), as they are called in Canada, in March 2010 [1]. To date, Health Canada has approved three SEBs within the product classes of human growth hormone and TNF-inhibitor, for use in Canada [2].

The establishment of the new CGPA Biosimilars Board signifies the focus the Canadian generics industry is placing on ensuring that Canada is a viable market for biosimilars, according to Mr Robidoux. ‘The establishment of clear rules for the approval and reimbursement of cost-saving biosimilar products in Canada is essential for the ongoing sustainability of both public and employer-sponsored drug plans, and to ensure that more Canadians can gain access to the treatments they need,’ he added.

In Canada, four of the five top-selling prescription drugs are biologicals with annual sales of more than CA$2 billion.

The CGPA Biosimilars Board aims to play an important role in educating patients, prescribers and drug plan sponsors about biosimilars in Canada.

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. 

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References
1.  GaBI Online - Generics and Biosimilars Initiative. Canadian guidelines for subsequent entry biologics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 27]. Available from: http://www.gabionline.net/Guidelines/Canadian-guidelines-for-subsequent-entry-biologics 
2.  GaBI Online - Generics and Biosimilars Initiative. Subsequent entry biologics approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 27]. Available from: www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada 

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