New guidance for biosimilars
Updated product monograph guidance
On November 14 2016 Health Canada adopted the Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs, which replaces the Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (March 5 2010). Health Canada now uses the term 'biosimilar' instead of 'subsequent entry biologic'. The new guidance document applies to all biologic drug submissions where the sponsor seeks authorisation for sale based on demonstrated similarity to a previously approved biologic drug in order to present a reduced clinical and non-clinical package. Health Canada has also recently published a revised Fact Sheet: Biosimilars, which provides general information on:
- biologic drugs;
- biosimilars;
- the applicable regulatory framework; and
- access to biosimilars.
Updated product monograph guidance
On December 9 2016 Health Canada released revised versions of Part I: Heath Professional Information and Part II: Scientific Information of the product monograph guidance document. The revisions are intended to make health professional information easier to read and critical safety information easier to find in the Canadian product monograph. From June 9 2017 certain submissions for biologics, radiopharmaceuticals and prescription pharmaceuticals will have to be filed in the revised format. Specifically, the 2016 format will be required for new drug submissions, as well as abbreviated new drug submissions and supplements to abbreviated new drug submissions where the corresponding innovator product monograph is in the 2016 format.
For further information on this topic please contact Paul Jorgensen or Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar website can be accessed at www.smart-biggar.ca.