Number of biosimilar submissions increased more than 400% from 2016 to 2025, while departmental resources remained ‘relatively constant’

The South Korea headquarters of Celltrion, a global drugmaker with offices in Canada. Celltrion submitted three products for approval to Health Canada in 2024 that are now overdue.

Health Canada says it is working to reduce a backlog of pharmaceutical submissions that is causing a delay in cheaper versions of high-cost biologic drugs coming to market.

The pledge to speed up the reviews of the biosimilar class of drugs is part of a wider effort by the department to reduce red tape, which Health Minister Marjorie Michel has called a priority for the federal government.

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