Consultation on Revised Guidance for Subsequent Entry Biologics


Food and Drug Law
Food and Drug Regulatory Law

Health Canada has released a draft version of the revised guidance document Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance) for consultation, and is requesting comments by February 15, 2016.

Proposed revisions to the SEB Guidance include (i) further considerations of the selection of a reference biologic drug; (ii) further considerations of performance of non-clinical and clinical studies for SEBs, including discussion with respect to immunogenicity, the use of the most sensitive population in clinical trial design and a new section on extrapolation; (iii) updates on periodic benefit-risk evaluation reports (PBRERs) and labelling changes for product class type-specific safety information; and (iv) a section on early consultation with Health Canada and a pilot program for SEB Scientific Advice Meetings.

Interested parties can submit comments by February 15, 2016 to, using the template here.

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