Canadian guidelines for subsequent entry biologics Posted 29/10/2010

Last update: 11 February 2014

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 finalized guidelines for subsequent entry biologics (SEBs) 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 authorization of SEBs in Canada.

1. Overarching Guidelines
These guidelines cover all subsequent entry biologics:

Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
Date: 5 March 2010
www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php

2. Accompanying Guidance
These guidance documents are also relevant for subsequent entry biologics: 

Publication of Updates to Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations
Date: 8 March 2010
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
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
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.

Editor’s comment
Subsequent entry biologics approved in Canada have been authorized following a strict regulatory process in the same way as is required for approval of biosimilars in the European Union. European Medicines Authority (EMA) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals and also include a rigorous comparability exercise with the reference product.

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Canadian guidelines for generics

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Source: Health Canada

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