The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in August 2020.

Biosimilars approved in Canada

Since our last update in August 2020, Health Canada approved 11 biosimilars of 5 innovator products. This includes approval of 2 biosimilars of 2 innovator products in 2021.

This brings the total Health Canada approvals to 36 biosimilars of 14 innovator products. The complete list is below; items 37 and later are added after the initial publication of this article.

Note: italicized products are not yet marketed. This table is updated on a regular basis. Current as of October 21, 2021.

* Review time calculated from date of filing to the earlier of the date approval and IP hold, where available.