Health Canada Revises Biosimilar Approval Guidance

Biotech & pharma

Health Canada revises guidance document on biosimilar submission requirements

Health Canada has released a revised edition of its guidance and regulations for the approval of biosimilars. The document is titled ‘Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs’ and outline regulations around the development of pharmaceuticals. The original document, titled ‘Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)’, was released in March 2010. The revised document aims to bring terminology up to date, as well as addressing the original document’s lack of clarity around the determination of similarity to a reference biologic drug.


A key update to the guidelines includes the replacement of the term ‘Subsequent Entry Biologics’ with ‘biosimilar biologic drug’, or ‘biosimilar’. In addition, biosimilars are now referred to as being ‘similar’ to the reference biologic drug, rather than the previous terminology of being ‘comparable’. Other terminology has also been updated throughout the document to be brought into line with terminology used by the U.S. Food and Drug Administration and European Medicines Agency.

Clarification on determination of similarity

The revised guidance document clarifies requirements for what determines similarity; in particular, data requirements. Physicochemical and biological characterization data, relevant sample analysis, stability data, and data from several batches of the biosimilar and reference biologic should be evaluated by the manufacturer in order to show similarity.

Clinical and non-clinical studies

Further guidance regarding clinical and non-clinical studies has also been included in the latest guidance document on submission requirements for biosimilars. Health Canada has revised that in cases where similarity has already been well established by structural and functional studies – and in vitro studies also point to similarity, while in vivo studies may not be required in non-clinical studies. In clinical studies, further guidance and consideration in relation to the design of studies has been included for clarification.

New reference biologic drug options

The revision includes updated advice allowing multiple reference biologics to be used, in some circumstances, in the development of the biosimilar (although it is generally preferred that a sole reference biologic drug is used). The revised guidance document also provides simplified requirements and solutions for the selection of reference biologic drugs that are non-Canadian.





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