The CADTH Common Drug Review (CDR) approach to reviewing Inflectra followed the CDR Procedure and Submission Guidelines for Subsequent Entry Biologics (March, 2014). The CDR team reviewed the information provided by the manufacturer regarding product information, indications under review, the manufacturer’s requested listing criteria, biosimilarity, extrapolation, and cost. Clinical Study Reports and published articles were also appraised. Reviewers provided a critical appraisal of the clinical evidence, a discussion of extrapolation from the indications of rheumatoid arthritis (RA) and ankylosing spondylitis (AS) to inflammatory bowel disease (IBD), and an evaluation of cost.

Contents

• Abbreviations
• Executive Summary
• 1. Product Information
  • 1.1. Overview of the SEB Product
  • 1.2. Overview of the Reference Prodcut
• 2. Indications
  • 2.1. Health Canada-Approved Indications
• 3. Manufacturer’s Requested Listing Criteria
  • 3.1. Requested Listing Criteria
  • 3.2. Rationale for Requested Listing Criteria
• 4. Biosimilarity
  • 4.1. Quality Information
  • 4.2. Key Clinical Studies
  • 4.3. Pharmacokinetics
  • 4.4. Immunogenicity
• 5. Critical Appraisal of Clinical Studies
  • 5.1. Intenal Validity
  • 5.2. External Validity
• 6. Extrapolation of Indications
  • 6.1. Manufacturer’s Rationale for Extrapolation
  • 6.2. Health Canada’s Conclusion on Extrapolation
  • 6.3. International Regulatory Conclusions on Extrapolation
  • 6.4. CDR Comments on Extrapolation
• 7. Cost Comparison
• 8. Discussion
• 9. Conclusion
• APPENDIX 1. Additional Data
• APPENDIX 2. Drug Plan Listing Status for Reference Product
• APPENDIX 3. Summary of Patient Input
• References

This review report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH).

Through the CADTH Common Drug Review (CDR) process, CADTH undertakes reviews of drug submissions, resubmissions, and requests for advice, and provides formulary listing recommendations to all Canadian publicly funded federal, provincial, and territorial drug plans, with the exception of Quebec.

The report contains an evidence-based clinical and/or pharmacoeconomic drug review, based on published and unpublished material, including manufacturer submissions; studies identified through independent, systematic literature searches; and patient-group submissions. In accordance with CDR Update — Issue 87, manufacturers may request that confidential information be redacted from the CDR Clinical and Pharmacoeconomic Review Reports.

The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment with respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this document to ensure that its contents are accurate, complete, and up-to-date as of the date of publication, CADTH does not make any guarantee to that effect. CADTH is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this document or in any of the source documentation.

This document is intended for use in the context of the Canadian health care system. Other health care systems are different; the issues and information related to the subject matter of this document may be different in other jurisdictions and, if used outside of Canada, it is at the user’s risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.

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