Health Canada has recently released the revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (the "Guidance Document"), replacing the March 2010 Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics. The Guidance Document is meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations, but does not have the force of law. The Guidance Document is one of the primary resources provided by Health Canada regarding approval of biosimilars.
Health Canada has significantly revised and updated the Guidance Document to use key terms that are now consistent with the U.S. Food and Drug Administration and European Medicines Agency. The updated and highly-anticipated Guidance Document also contains new provisions regarding clinical and non-clinical data requirements, labelling requirements, and criteria for selecting reference biologic products. Additionally, the Guidance Document also adds new instructions for satisfying the scientific review requirements of the Biologics and Genetic Therapies Directorate, authorization of indications, and a stance on interchangeability.
Some of the key updates are highlighted and discussed below:
| New Definition | The Guidance Document now uses the term 'biosimilar biologic drug' or 'biosimilar', instead of 'Subsequent Entry Biologics', which was formerly used in Health Canada's previous guidance document. |
| Changes to information requirements for clinical trial applications | The Guidance Document has included new factors to determine clinically meaningful differences between a reference and a biosimilar (section 2.3.3.3). |
| Changes to requirements for non-clinical information | The Guidance Document has simplified and reduced the requirements, including outlining when an in vivo study may not be required (sections 2.2 and 2.3.3.2). |
| New options for reference biologic drugs | The Guidance Document now permits the use of multiple reference biologic drugs under some circumstances (section 2.1). It also provides simplified requirements for supporting the selection of non-Canadian reference biologic drugs (section 2.1.3). |
| Explanation regarding the determination of similarity | The Guidance Document provides clarification regarding data that will be assessed in determining similarity, including comparative structural, functional, non-clinical, and clinical studies (section 1.3.4). |
| Further Guidance regarding quality considerations for biosimilars | The Guidance Document provides further guidance and acceptance of varied and different approaches regarding quality information and considerations for biosimilars versus the reference biologic drug (section 2.3.2). |
| More flexibility on indications | The Guidance Document will allow for a biosimilar sponsor to apply for the indication and condition of use held by the reference biologic drug (section 1.3.2). Clinical studies are not required to support approval for each listed indication, provided similarity has been established and a detailed scientific justification has been provided (section 2.3.3). |
| Revised labelling requirements | The biosimilar product monograph will now include safety and efficacy information from the product monograph of the reference biologic drug (section 2.3.5). |
| Risk-management plans | The Guidance Document provides guidelines regarding risk management that should be addressed (section 2.3.6). |
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