Market access: biosimilars no longer reviewed by CADTH

The Canadian Agency for Drugs and Technologies in Health (CADTH) released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that effective 1 June 2019, the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review. 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 (for further details please see "CADTH outlines revisions to biosimilar and pharmaceutical review programmes"). Reasons for the change include the prevention of possible delays to access new biosimilars and resource allocation at the CADTH. Therefore, biosimilars should be filed directly with the jurisdictions and the pCPA.

For further information on this topic please contact Urszula Wojtyra at Smart & Biggar by telephone (+1 416 593 5514) or email (uawojtyra@smart-biggar.ca). The Smart & Biggar website can be accessed at www.smart-biggar.ca.