Canada’s Intellectual Property Law Firm

CADTH update outlines revisions to biosimilar and pharmaceutical review programs

In its Common Drug Review (CDR) Update – Issue 133 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.