Policy statement: Content of product monograph for biosimilar biologic drugs – clinical comparative study results

The Guidance Document: Product Monograph (2020) and product monograph master template currently indicate that a biosimilar's product monograph (PM) should include the results of clinical comparative studies between the biosimilar and its reference biologic drug.

Extensive side-by-side comparative structural and functional studies provide the foundation of evidence for authorizing a biosimilar. These studies are more sensitive than clinical studies for detecting differences between a biosimilar and its reference biologic drug. For their part, non-clinical and clinical studies for biosimilars are intended to address potential areas of remaining uncertainty after comparative structural and functional studies have established high similarity.

Assessing similarity between a candidate biosimilar and its reference biologic drug differs from assessments to support the authorization of a generic pharmaceutical drug eligible for consideration through the Abbreviated New Drug Submission (ANDS) pathway.

As such, the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) has concluded that for biosimilars, the current PM format, in particular Part II: Scientific Information – Section 14 (Clinical Trials) inadvertently places unnecessary emphasis on clinical studies carried out for the purposes of demonstrating similarity. This is because the establishment of similarity is principally demonstrated by comparative structural and functional studies.

This policy statement communicates to stakeholders Health Canada's updated expectations regarding the content of PMs for biosimilars. Going forward, BRDD expects that sponsors will not include comparative clinical study results in the PM for biosimilars. These results are currently in sections 14.1 to 14.4, which cover:

  1. clinical trial design and study demographics
  2. study results
  3. PK/PD studies
  4. immunogenicity

Clinical trial information that appears in the reference biologic drug's monograph with respect to indications to be authorized for the biosimilar is currently in section 14.5. Continue to include it in in the PM for biosimilars.

Moreover, your PM master template should include this general statement above Part 1: Health Professional Information:

This policy statement does not apply to small molecule generic drugs authorized under the ANDS pathway. This is due to the differences in the basis of evidence used to authorize the sale of biosimilars and generic drugs under the Food and Drug Regulations.

This policy statement comes into effect immediately upon publication. We request that sponsors update the PM for existing biosimilar products at the next available opportunity. To reflect the intent of this policy statement, file the appropriate submission in accordance with Health Canada's Post-NOC guidance documents.

The results of comparative clinical studies and other studies provided to Health Canada to demonstrate similarity will still be made available:

The 2020 product monograph guidance document and PM master template will be amended at the earliest available opportunity to reflect the intent of this policy. Until then, sponsors of biosimilars should adhere to the policy set out in this statement, rather than Section 14 of the current PM guidance and template.

Contact us

Centre for Policy, Pediatrics and International Collaboration
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Building #6, 100 Eglantine Driveway
Tunney's Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601B

Email: brdd-cppic_brdd-cppci@hc-sc.gc.ca

Related links

Page details

Date modified: