Canadian guidelines for biosimilars

The regulatory body for approval of medicines in Canada is the Therapeutic Products Directorate of Health Canada.

Health Canada develops and enforces regulations under Canadian governmental legislation.

Health Canada applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality.

Health Canada finalised guidelines for biosimilars or subsequent entry biologics (SEBs) as they call them in March 2010.

The objective of the guidance is to enable sponsors to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorisation of SEBs in Canada.

1. Specific Guidelines
These guidelines are specific to the type of biosimilar product:
Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
Date: 5 March 2010
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php

2. Accompanying Guidance
Publication of Updates to Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations
Date: 8 March 2010
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/data_donnees_protection-eng.php

Publication of Updates to Guidance Document: Patented Medicines (Notice of Compliance) Regulations
Date: 8 March 2010
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.php

Questions and Answers to Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
Date: 27 May 2010
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/01-2010-seb-pbu-qa-qr-eng.php

Submission requirements for SEBs are determined by Health Canada on a case by case basis, and may include, but not be limited to:

• A complete chemistry and manufacturing data package for the SEB.
• A rationale for the choice of the innovator biologic as the comparator and extensive published information on its safety and efficacy.
• Sufficient characterization information to demonstrate both chemical and biological comparability of the SEB to the innovator product chosen as the comparator.
• Sufficient comparative animal toxicity and toxicological data, where appropriate.
• Pharmacodynamic data to demonstrate comparable bioactivity based on parameters or surrogate markers that are clinically relevant and validated.
• Pharmacokinetic data to demonstrate comparable bioavailability of the SEB to the innovator product based on suitable validated pharmacokinetic parameters.
• Data characterizing the immunogenic profile of the SEB in humans and its potential impact on safety and efficacy.
• A clinical package which demonstrates the safety and efficacy of the SEB including comparative studies between the SEB and innovator products, and data for the innovator product in the public domain. The study design and clinical comparability margins are important and should be given careful consideration and justification.