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Consultation on CADTH’s Proposed Revisions to the Biosimilar Review Process, Resubmission Criteria, and Other Operational Considerations for CDR and pCODR

Published on: August 1, 2017
Result type: News

Call for Feedback Deadline: September 15, 2017, at 5:00 p.m. ET by email to: feedback@cadth.ca

CADTH is inviting stakeholder comments and feedback on the following:

  • proposed revisions to the process for reviewing biosimilars submitted through CADTH’s Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs
  • proposed revisions to the resubmission criteria for CDR and pCODR processes
  • proposed changes to the checkpoint timeline for the pCODR program.

1. Proposed Revisions to CADTH’s Biosimilar Review Process

Biologic drugs come from living organisms or from their cells, and are often made using biotechnology. They are used to treat diseases and medical conditions including anemia, diabetes, inflammatory bowel disease, psoriasis, rheumatoid arthritis, hormone deficiency, and some forms of cancer. A biosimilar biologic drug, or biosimilar, is a drug demonstrated to be highly similar to a biologic drug (known as the reference biologic drug) that was already authorized for sale by regulatory bodies (i.e., Health Canada). Biosimilars are approved based on a thorough comparison to a reference drug and may enter the market after the expiry of reference biologic drug patents and data protection.1-3

For a biosimilar review, Health Canada evaluates the information provided by the manufacturer of the biosimilar to confirm that the biosimilar and the reference biologic drug are similar and that there are no clinically meaningful differences in safety and efficacy between the biosimilar and reference drug. The regulatory approval of a biosimilar drug relies in part on prior information regarding safety, efficacy and effectiveness that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount and type of original data required.4

Health Canada may authorize a biosimilar for use in more than one indication because of the rigorous demonstration of similarity between the biosimilar and the reference biologic drug. Since a biosimilar is very similar in structure and function to a reference biologic drug with well-established safety and efficacy in many cases clinical studies do not need to be repeated for each indication.4

Given the type of data required to support biosimilar authorization differs from that required for a biologic drug, CADTH is proposing revisions to the submission process for biosimilars through its CDR and pCODR programs that would reduce duplication of work, optimize resources, and ensure that all participating jurisdictions benefit from a single approach to evidence review that would facilitate decision-making and keep with CADTH’s value of excellence. It is proposed that CADTH would support the timely review of biosimilars by providing a centralized coordinating role, working in collaboration with Health Canada, the pan-Canadian Pharmaceutical Alliance and the participating federal, provincial and territorial public drug plans (with the exception of Quebec) and provincial cancer agencies to support improved access for patients. Please access the consultation details by clicking this link: CADTH’s Proposed Revisions to the Biosimilar Review Process

2. Resubmission Criteria for CDR and pCODR Processes

CADTH is initiating stakeholder consultation on revisions to its CDR and pCODR resubmission eligibility criteria that would remove the requirement of a new randomized controlled trial to file a resubmission based on improved efficacy. Please access the consultation details by clicking this link: Resubmission Criteria for CDR and pCODR Processes

3. Proposed Changes to the Checkpoint Timeline for the PCODR Program

Currently, an electronic version of the submitter responses to the clarifying questions and requests for additional information must be provided to pCODR at least one (1) business hour in advance of the scheduled Checkpoint Meeting.

To allow the pCODR Review Team sufficient time to review the responses, CADTH is proposing to make changes to the pCODR procedures that would request the submitter responses to the clarifying questions and any applicable requests for additional information be provided at least one (1) business day in advance of the scheduled Checkpoint Meeting so that these can be provided to the pCODR review team before the interactive meeting. A submitter will continue have 10 business days to prepare responses to the clarifying questions and additional information to the pCODR program.

Next Steps

Following the consultation period, CADTH will carefully assess all stakeholder feedback before announcing any decisions regarding changes to the current CDR and pCODR processes. Any future changes will be applied to the CDR and pCODR procedures.

How to Submit Your Feedback

To provide feedback, you must identify yourself — feedback provided by individuals who do not identify themselves and the organization they represent will not be considered.

Only one response per organization will be considered. If more than one response is received, only the first will be considered.

Feedback must be provided in 11-point font using this feedback template and saved in one of the following formats:

  • Microsoft Word document (.doc or .docx)
  • Unlocked PDF document that permits copying and pasting of text.

Feedback should be presented clearly and succinctly, and submitted by September 15, 2017 at 5:00 p.m. ET.

If you have any questions about the feedback process, please email us at feedback@cadth.ca.

We thank you in advance for your interest.

References

  1. Fact sheet: biosimilars [Internet]. Ottawa: Health Canada; 2016 Nov.  [cited 2017 Jul 28]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html
  2. Biosimilar drugs [Internet]. Ottawa: CADTH; 2017 Nov.  [cited 2017 Jul 28]. Available from: https://cadth.ca/sites/default/files/pdf/biosimilar_drugs_professional_en.pdf
  3. Biosimilar drugs: your questions answered [Internet]. Ottawa: CADTH; 2017 Nov.  [cited 2017 Jul 28]. Available from: https://cadth.ca/sites/default/files/pdf/biosimilar_drugs_patient_en.pdf
  4. Guidance document: information and submission requirements for biosimilar biologic drugs [Internet]. Ottawa: Health Canada; 2016 Nov.  [cited 2017 Jul 28]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/information-submission-requirements-biosimilar-biologic-drugs-1.html