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Frequently Asked Questions: Submission Guidelines for Biosimilars

Why is the review process for biosimilar products changing?

Our experience reviewing biosimilar products, coupled with input from stakeholders, allowed us to identify key areas where our process could be streamlined for the benefit of patients, clinicians, and governments. As the number of biosimilar products submitted for review increases, these changes will allow CADTH to continue delivering evidence and advice as efficiently as possible.

By revising the review process, we can reduce duplication, optimize resources, and ensure that all participating jurisdictions benefit from a single approach to evidence review that supports timely decision-making.

Was input from stakeholders considered during the revision process?

Absolutely, stakeholder consultation is an integral step before CADTH considers making procedural changes to any of our programs. We launched an open consultation on the biosimilar review process in August 2017 and received input on our proposed revisions from 25 different sources, including patient groups, clinicians, manufacturers and others.

What are the major changes to the process compared to the previous review process?

Highlights of the revised review process are described below.

Fewer submissions requirements

A modified submission package for biosimilars will reduce duplication of effort and resources. A new CADTH Biosimilar Summary Dossier Template has been created, which is an abbreviated version of the previous biosimilar submission template and includes fewer submission requirements.

Manufacturers must complete and file the new dossier along with their submission package and it will be reviewed by our clinical and economic reviewers. The completed dossier will become the CADTH Biosimilar Summary Dossier that is publicly posted on the CADTH website.

A reduced timeline

The overall timeline of the review process will be cut in half to approximately three months, from the current six-month timeline.

No reimbursement recommendation from CADTH Expert Committees

The CADTH Biosimilar Summary Dossier will not be brought forward to CADTH’s Canadian Drug Expert Committee or pCODR Expert Review Committee and no reimbursement recommendation will be issued.

Our CADTH reviewers will review the manufacturer-completed template, provide a summary of stakeholder input, and comment on the manufacturer’s cost-comparison table. Following a review and revision period of the draft summary dossier, CADTH will forward the final Biosimilar Summary Dossier to the applicant and the participating drug plans. The final dossier will also be posted on the CADTH website.

New Fee Structure

All biosimilar submissions are subject to CADTH’s application fees, as outlined in the new Guidelines for Manufacturers on Application Fees for CADTH Pharmaceutical Reviews.

What is the objective of the Biosimilar Summary Dossier?

The CADTH Biosimilar Summary Dossier is the entry point for manufacturers to provide the information for review of a biosimilar product. The Dossier is meant to capture all relevant information related to the biosimilar of interest for consideration by the pan-Canadian Pharmaceutical Alliance and the participating jurisdictions to inform their decision-making processes.

Through the revised biosimilar process, CADTH can efficiently:

  • gather important cost information for biosimilar products;
  • consolidate input and feedback from a diverse range of stakeholders; and
  • consolidate potential implementation issues that the pan-Canadian Pharmaceutical Alliance and jurisdictional drug plans must consider throughout their decision-making processes.

Will evidence for switching from a reference product to a biosimilar be included in the final CADTH Biosimilar Summary Dossier?

CADTH will determine on a case-by-case basis whether it will review the evidence for switching from the reference product or a biosimilar to the biosimilar under review. This determination is made in consultation with the participating public drug plans and may be influenced by the volume and quality of available evidence, as well as reimbursement and switching policies for other biosimilars for the same reference drug and/or indications.

If a switching review will be undertaken, CADTH will advise the applicant in writing and the review will be conducted via CADTH’s Rapid Response Program.

CADTH will not issue recommendations on whether or when one therapeutic product can be switched (or substituted) for another — this decision will be made by the jurisdictions.

Are there changes to the current patient input process? How will patient input be used?

Patient input is a critical aspect of all our drug reviews, including the new process for biosimilars. We will continue to notify stakeholders of patient input opportunities via our E-Alert.

A new biosimilar patient input template has been created for use by patient groups. This template provides specific questions and prompts to help guide patients to provide the most relevant information. All patient input provided will be posted publicly as part of the CADTH Biosimilar Summary Dossier and shared with the pan-Canadian Pharmaceutical Alliance and the participating jurisdictions to inform their decision-making processes.

What information will be publicly available?

CADTH is committed to providing an open and transparent drug review process for biosimilars.

All the information included by the manufacturer in a biosimilar submission template is subject to dissemination and publication by CADTH. The final CADTH Biosimilar Summary Dossier will be publicly posted and there is no opportunity for an applicant to request redaction of any information.