Update on biosimilars in Canada - April 2021

Smart & Biggar

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 (italicized products are not yet marketed)...

Please see full Publication below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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