Notice to Stakeholders: Release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug

May 15, 2017
Our file number: 17-105256-845

Health Canada is pleased to announce the release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug.

This template is intended to be used in conjunction with the Guidance Document:  Information and Submission Requirements for Biosimilar Biologic Drugs and the Guidance Document - Product Monograph to guide sponsors in the preparation of biosimilar product monographs.

The new template aligns with the "Product Monograph Guidance, Part I: Health Professional Information and Part II: Scientific Information" and sample "Product Monograph Template- Standard", which were consulted upon from December 19, 2014 to March 4, 2015.

All manufacturers are required under the Food and Drug Regulations to ensure drug product labelling, including the product monograph, is up to date and supports safe conditions of use. Revisions should be initiated by the manufacturer whenever significant updating of the product monograph is required in order to incorporate additions or other changes related to safety (particularly with respect to warnings, precautions, adverse reactions, and mode of administration) that may be necessary as a result of newly available information.

Implementation

Biologic New Drug Submissions are required to file under the 2016 format for parts I, II and III of the product monograph as of June 9, 2017, as stated in the Notice - Final Release: Part I - Health Professional Information and Part II - Scientific Information of the Guidance Document - Product Monograph. While Health Canada recognises that reference biologic drug product monographs may continue to follow the 2004 format until June, sponsors are encouraged, on a voluntary basis, to use the biosimilar template to prepare product monographs immediately.

Any questions should be directed to:

Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
Building #6, 100 Eglantine Driveway
Tunney’s Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601B

Fax number: 613-952-5364
Email: BGTD.OPIC@hc-sc.gc.ca