Posted by Michael Wonder on 01 Aug 2017
Proposed revisions to CADTH’s biosimilar review process
1 August 2017 - Given the type of data required to support biosimilar authorization differs from that required for a biologic drug, CADTH is proposing revisions to the submission process for biosimilars through its CDR and pCODR programs that would reduce duplication of work, optimize resources, and ensure that all participating jurisdictions benefit from a single approach to evidence review that would facilitate decision-making and keep with CADTH’s value of excellence.
It is proposed that CADTH would support the timely review of biosimilars by providing a centralized coordinating role, working in collaboration with Health Canada, the pan-Canadian Pharmaceutical Alliance and the participating federal, provincial and territorial public drug plans (with the exception of Quebec) and provincial cancer agencies to support improved access for patients.
