1. Update on Revised Process for Biosimilars
In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the submission and review process for biosimilars through CADTH’s Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs. Based on feedback from stakeholders, CADTH will be implementing a revised process for biosimilars. CADTH is currently finalizing the details of the revised biosimilar review process with complete details to be announced in February 2018. Highlights of this revised process will include:
- a new, abbreviated, submission review template
- fewer category 1 requirements
- a shorter review period.
2. Clarification Regarding Eligibility Assessments for Resubmissions
All completed resubmission eligibility assessments may be shared by CADTH with the following:
- federal, provincial, territorial governments, including their agencies and departments
- pan-Canadian Pharmaceutical Alliance (pCPA) office.