Health Canada issues draft revised SEB guideline

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Health Canada issues draft revised SEB guideline

INICIO/Directrices | Posted 15/01/2016 0 Post your comment

Canada’s federal department responsible for health, Health Canada, has issued a new draft revised guidance document on the information and submission requirements for subsequent entry biologics (SEBs). The draft guideline, issued on 7 December 2015, provides guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

Information and submission requirements for Subsequent Entry Biologics (SEBs)
Date: 13 August 2015
Released for consultation: 7 December 2016
End of consultation: 15 February 2016
www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/biolog/submission-seb-exigences-pbu-eng.pdf

The new draft guidance will replace the previous guidance of 5 March 2010 [1].

The new draft guidance contains an extra policy statement:
‘Once granted a Notice of Compliance (NOC), an SEB becomes a new drug with all of the associated regulatory requirements. However, the SEB designation is retained for the entire life span of the product. In addition, an SEB should not be used as a reference biologic drug for another SEB submission.’

The new draft guidance also contains a definition of extrapolation, which was not in the previous guidance:

‘The application of data from the comparability package pharmacokinetic/pharmacodynamics studies, and clinical studies in at least one indication to other indications held by the Canadian reference biologic drug.’

Finally, the new draft guidance also clarifies what requirements in the guideline are obligatory and which are ‘advised but not required’.

The new draft guidance document is being distributed for comment purposes only. The deadline for comments is 15 February 2016.

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
Subsequent entry biologics approved in Canada

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Canadian guidelines for subsequent entry biologics biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Guidelines/Canadian-guidelines-for-subsequent-entry-biologics

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Source: Health Canada