The CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (Non-Cancer) and the CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars (Cancer) provide an overview of the Common Drug Review procedures and guidance to applicants for biosimilar submissions. The new guidelines are effective as of February 13, 2018.
CADTH reports the following key changes to reviews and resubmissions of biosimilars.
Shorter timeline. The timeline for review is reduced to three months from the current six months.
Fewer submission requirements. The previous biosimilar submission templates have been abbreviated to reduce submission requirements.
New fee structure. Biosimilar submissions are subject to the new Guidelines for Manufacturers on Application Fees for CADTH Pharmaceutical Reviews.
No reimbursement recommendations. CADTH will not issue reimbursement recommendations. CADTH reviewers will, however, review manufacturer-completed templates, provide a summary of stakeholder inputs and comment on the manufacturer’s cost-comparison table This information will be sent to the applicant, participating drug plans and will be available on the CADTH website.
According to CADTH, these changes are intended to reduce duplication, optimize resources, and ensure all participating jurisdictions benefit from a single approach to evidence review.
Links:
CADTH announcement.
CADTH Frequently Asked Questions: Submission Guidelines for Biosimilars
