In its Common Drug Review (CDR) Update – Issue 133 (with further details in Revisions to CADTH’s Biosimilar and Resubmission Processes, Other Administrative Changes and New Fee Guidance for Applications to CADTH’s Pharmaceutical Review Programs) published on February 13, 2018, CADTH announced revisions to its biosimilar and administrative review process. This update includes the following:
- Revisions to CADTH’s biosimilar process which creates a streamlined approach for biosimilar reviews through shorter timelines, fewer submission requirements and abbreviated biosimilar summary dossier templates;
- The announcement that application fees now apply to all CDR submissions and resubmissions irrespective of the notice of compliance / notice of compliance with conditions issuance date;
- A new fee guidance for pharmaceutical review programs which includes a new, reduced fee for the new biosimilar review process and an annual fee adjustment based on the Consumer Price Index; and
- New patient input templates for biosimilars, which offers specific prompts for biosimilar review.
Other updates include the issuance of new administrative forms, such as a revised pre-submission information requirements form for advanced notice, a revised application overview template and updated contact information.