CADTH Revisions to the Biosimilar Review Process and Resubmission

CADTH Revisions to the Biosimilar Review Process and Resubmission

Posted: Wednesday April 11th, 2018

Author: Pinky Mazumder 

In late 2017, the Canadian Agency for Drugs and Technologies in Health (“CADTH”) announced an open consultation on proposed changes to the Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (“pCODR”) for the review of biosimilar drug products. The consultation also addressed the resubmission eligibility criteria for drugs subject to CDR or pCODR along with various administrative changes. On February 2018, CADTH announced new operational changes resulting from the consultation and to enhance the drug review process.

Streamlining Biosimilar Review 

In an effort to prevent redundancy of work and to optimize resources during the review of biosimilar drug products, CADTH announced a streamlined approach for biosimilar reviews to help improve its access to the patients in need. This revision also responded to the increased number of biosimilar submissions for review. This streamlined approach includes a reduced review timeline, less submission requirements, as well as an abbreviated dossier template of the biosimilar subject to review

As per the streamlined process, the target timeline of the Screening, Review, and Publishing phases of the Common Drug Review is a total of 44 business days, which is a significant reduction in time from the current process. Sponsors are however advised to submit an advance notification of at least 30 days (³ 120 days is preferred) before the submission is filed. This notification helps CADTH prepare and plan for the resources and experts appropriate for the CDR of the biosimilar in question. This streamlined process has been made effective for all new biosimilar submissions since February 13, 2018. Moreover, CADTH has also reduced the fee for the review of a new biosimilar to $7,050 as part of the new CADTH guideline on Application Fees for Pharmaceutical Reviews. The guideline highlights the costs of drug review for the CDR and pCODR programs for different drugs in Schedule A, B, C, and D as per the Food and Drugs Act. The new review process for biosimilars will also reduce submission requirements with an abbreviated CADTH Biosimilar Summary Dossier Template.

 Resubmission Criteria for pCODR

Following the 2017 consultation, CADTH aims to increase transparency and predictability for drugs in the pCODR program. The resubmission program will now require the submission of a pCODR Resubmission Eligibility Form and information on studies that address the concerns identified by the pCODR Expert Review Committee (pERC) recommendation. This information will be assessed by the pERC panel for its eligibility for resubmission. For more information on the revisions to the CADTH drug review process, please refer to the links below. 

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Revisions to CADTH’s Biosimilar and Resubmission Processes, Other Administrative Changes and New Fee Guidance for Applications to CADTH’s Pharmaceutical Review Programs

CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars

Guidelines for Manufacturers on Application Fees for CADTH Pharmaceutical Reviews