Canada’s Intellectual Property Firm

Biosimilars no longer reviewed by CADTH

Authored byUrszula Wojtyra

The Canadian Agency for Drugs and Technologies in Health (CADTH) released  Issue 8 of its Pharmaceutical Reviews Update announcing updates, including to its Procedure and Submission Guidelines for the CADTH Common Drug Review. The update also announced that effective June 1, 2019, CADTH will no longer review biosimilars through the Common Drug Review (CDR) or the pan-Canadian Oncology Drug Review (pCODR). The decision was made subsequent to an internal review, which included a consultation with the pan-Canadian Pharmaceutical Alliance (pCPA), of the streamlined biosimilar review process launched in February 2018 (reported  here). Reasons for the change include the prevention of possible delays to access of new biosimilars and resource allocation at CADTH. Biosimilars should therefore be filed directly with the jurisdictions and pCPA.